Apparatus and kits for fluid infusion

ABSTRACT

An infusion device includes a housing with an interior chamber sized and configured to hold at least a flange and plunger of a syringe, a trigger held by the housing, and a lever in communication with the trigger and including an upwardly extending cam with a cam path having an upper end. The cam is in communication with the flange of the syringe. In response to actuation of the trigger to dispense fluid from the syringe, the upper end of the cam travels upward above the syringe and longitudinally toward a dispensing end of the syringe to linearly translate the plunger of the syringe in a first direction to dispense fluid from the syringe. To refill fluid into the syringe, the upper end of the cam travels downward and longitudinally away from the dispensing end of the syringe to linearly translate the plunger in a second direction to intake fluid.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/612,668, filed Jun. 2, 2017, entitled “Apparatus and Kits for FluidInfusion,” which is a continuation application of InternationalApplication No. PCT/US2016/019167, filed Feb. 23, 2016, entitled“Apparatus and Kits for Fluid Infusion,” which claims the benefit of andpriority to U.S. Provisional Application Ser. No. 62/274,566 filed Jan.4, 2016, entitled “Apparatus and Method for Rapid Intraosseous FluidInfusion,” and U.S. Provisional Application Ser. No. 62/187,367 filedJul. 1, 2015, entitled “Apparatus and Method for Rapid IntraosseousFluid Infusion,” and U.S. Provisional Application Ser. No. 62/120,021filed Feb. 24, 2015, entitled “Apparatus and Method for RapidIntraosseous Fluid Infusion,” the contents of each of which are herebyincorporated by reference as if recited in full herein.

TECHNICAL FIELD

The present disclosure relates to dispensing medical fluid from asyringe. More particularly, the present disclosure relates to mechanismsand methods for syringe loading and dispensing fluid with assistance.

BACKGROUND

Rapid fluid administration is essential for patients suffering fromshock, a life-threatening illness resulting from a variety of conditionsincluding bacterial sepsis, hemorrhage, trauma, severe dehydration, andanaphylaxis. The American Heart Association's Pediatric Advanced LifeSupport (PALS) guidelines, the American College of Critical CareMedicine, and the Surviving Sepsis Campaign guidelines for adultsrecommend rapid fluid resuscitation as a key element of initial therapy.For example, PALS calls for 20 ml per kilogram of body weight to beinfused over 5 minutes, and up to 60 ml/kg in the first 15 minutes.

In practice timely infusion of recommended fluid volumes is rarelyachieved. This is often due to the difficulty of obtaining intravenous(IV) access in the setting of critical illness, and to the technicalbarriers to the infusion of large volumes of fluid. When IV access isdifficult to obtain, the preferred technique is now intraosseous (IO)access, in which a needle is drilled directly into one of the long bonesthe arm or leg, and fluid is administered through the bone marrow intothe central circulation. While IO infusion has revolutionized theapproach to rapid access for fluid and medication administration inemergency medicine, it presents an additional challenge due to theresistance of the bone marrow, which makes rapid infusion of fluiddifficult. These challenges are particularly common in children.

The increased resistance of bone marrow is similar to flow throughsmall-bore or long IV catheters, and limits the ability of healthcareproviders to deliver recommended volumes of resuscitation fluidsrapidly.

Healthcare providers use several methods used to deliver fluid rapidlyin these situations, include gravity, infusion pumps, pressure bagsapplied to the fluid reservoir, and hand-operated syringes, andmechanical rapid-infusion systems.

The fastest and most practical methods in higher-resistance situationsare the hand-operated syringe techniques. The standard set of componentsused includes a fluid reservoir, a syringe, a three-way stopcock, and IVtubing linking these components with the IO or IV port. The userwithdraws the plunger to fill the syringe from the fluid reservoir,turns the stopcock, and then depresses the plunger to drive the fluidthrough the IO or IV port and into the patient. The process is repeatedmultiple times until the desired volume has been delivered.Alternatively, one provider fills syringes from the IV fluid bag, whileanother connects the syringe, administers the fluid, disconnects theempty syringe, and repeats the process.

Both of these methods require emergency healthcare providers toeither: 1) use great force with a large-volume syringe, often with twohands, and quickly resulting in user fatigue, or 2) to refill asmall-bore syringe multiple times to achieve adequate volume, resultingin slow administration times and significant distraction for one or moreworkers. In either case two providers are often necessary, with one userinfusing the fluid, and the other refilling syringes or operating thestopcock, and adequate fluid volumes are rarely achieved within therecommended time period.

Consider the example of a 40 kg child with traumatic injury and massiveblood loss, who has a tibial IO needle as his only access. This childmay require rapid infusion of 40-80 ml/kg of blood products, for a totalof 1600-3200 ml. Repeated doses using a standard technique and 20 mlsyringe would require 80-160 injections and the full attention of twohealthcare workers, resulting in slow resuscitation and inefficient useof resources. The total infusion time could be 15-20 minutes, welloutside the range of recommended rates, particularly in an activelybleeding child.

SUMMARY

This summary is provided to introduce in a simplified form concepts thatare further described in the following detailed descriptions. Thissummary is not intended to identify key features or essential featuresof the claimed subject matter, nor is it to be construed as limiting thescope of the claimed subject matter.

In some embodiments, an infusion device includes a housing with aninterior chamber that is sized and configured to hold at least a flangeand plunger of a syringe, a trigger held by the housing, and a lever incommunication with the trigger and comprising an upwardly extending camwith a cam path having an upper end. The cam is in communication withthe flange of the syringe. In response to actuation of the trigger todispense fluid from the syringe, the upper end of the cam travels upwardabove the syringe and longitudinally toward a dispensing end of thesyringe to linearly translate the plunger of the syringe in a firstdirection to dispense fluid from the syringe. To refill fluid into thesyringe, the upper end of the cam travels downward and longitudinallyaway from the dispensing end of the syringe to linearly translate theplunger in a second opposing direction to intake fluid into the syringe.

The housing may include a lower housing member and a lid attached to thelower housing member. The lid may increase in height betweenlongitudinally opposing ends of the housing to define an interior cavitythat encases the upward end of the cam.

The cam may include a slot inside a closed perimeter that defines thecam path, and may further include a laterally extending pin extendingthrough the slot of the cam. The cam and the pin may cooperate to movethe syringe in the first direction to dispense fluid and to move thesyringe in the opposing direction to intake the fluid. Optionally, theslot may have upper and lower arcuate ends.

The infusion device may further include a shuttle attached to alaterally extending bracket that engages the upper end of the cam tomove the syringe in the first direction to dispense fluid and to movethe syringe in the opposing direction to intake the fluid. Optionally,the bracket may include a first cross bar and a longitudinally spacedapart second cross bar which together define an opening above which theupper end of the cam can extend.

The interior chamber may be sized and configured to hold at least theflange and plunger of a respective syringe with a volumetric capacity ina range of 5 ml to 30 ml. The upper end of the cam may be configured totravel up and down a distance of between about 1.25 inches and about2.25 inches in the enclosed cavity during operative use of the infusiondevice. The cam may include a concave shape that faces the syringe.

The housing may be sized and configured to hold an elongate syringe bodyof the syringe in the interior chamber. The housing may have an upperportion that is visually transmissive over at least a portion thereofthat resides above the interior chamber. The device may further includea dual check valve attached to the dispensing end of the syringe with aninlet tube of the dual check valve extending out of one side of thehousing to orient the syringe to have visual indicia of fluid volumefacing upward. The inlet tube may extend outward perpendicular to theaxially extending valve body to be parallel with a laterally extendingplane of the flange of the syringe. Optionally, the flange may reside adistance between 3 and 5 inches from an axially extending centerline ofthe inlet tube. Optionally, the inlet tube may be fixedly or releasablyattached to a length of large bore tubing.

The infusion device may further include a dual check valve attached tothe dispensing end of the syringe with an inlet tube of the dual checkvalve extending out of one side of the housing. The lid may include aplurality of spaced apart downwardly facing apertures on or adjacent afront end thereof adjacent a dispensing end of the syringe, including afirst forwardmost aperture sized and configured to extend about atubular exit port of the dual check valve body and at least one secondaperture positioned on a right and/or left sidewall of the lid to beadjacent, but spaced longitudinally apart from, the first forwardmostaperture. The spacing may be in a distance of between 0.5 inches to 1inch, optionally about 0.8 inches.

The at least one second aperture on the right and/or left sidewall mayinclude a pair of second apertures that are symmetrically positionedacross from one another on the right and left sidewalls of the lid.

The lid may have opposing front and rear ends. The front end may have atip with a semicircular aperture. A front end of the lower housingmember may also include a tip with a semicircular aperture facing thesemicircular aperture in the tip of the lid to form a circular aperturewhen the lid is closed against the lower housing member.

The lid may have a front end having a tip with an aperture and at leastone sidewall proximate the tip may also have an aperture. The lowerhousing member may have a front end including a tip with an aperturefacing the aperture in the tip of the lid and an aperture on at leastone upwardly extending sidewall facing a respective aperture in acorresponding sidewall of the lid. Respective pairs of apertures fromthe lid and lower housing member may align to form respective ports whenthe lid is closed against the lower housing member.

A front end of the lid may have a tip with a downwardly extendingsemicircular aperture and at least one sidewall proximate the tip thatalso may have a downwardly extending semicircular aperture. The lowerhousing member may have a front end residing under the front end of thelid. The front end of the lower housing member may include a tip with anupwardly extending semicircular aperture facing the semicircularaperture in the tip of the lid and an upwardly facing semicircularaperture on at least one upwardly extending sidewall facing a respectivesemicircular aperture in the sidewall of the lid. Respective pairs ofsemicircular apertures in the lid and lower housing member may formcircular apertures when the lid is closed against the lower housingmember.

A center of an aperture formed by at least one pair of aligned aperturesof a sidewall of the lid and lower housing member may reside spacedapart a distance in a range of 0.7 inches to 1 inch from a syringe neckholding segment in the interior chamber to thereby provide a positiveorientation of a check valve with respect to visual indicia on a syringewhen mounted inside the interior chamber.

The interior chamber may have a first compartment sized and configuredto hold a syringe body that merges into a smaller region for a lengththat is sized and configured to hold a neck of a respective syringe. Theinterior chamber first compartment may merge into a second compartmentthat extends to a tip and can be sized and configured to hold a dualcheck valve body therein so that an exit port extends out of the tip ofthe lid and an underlying lower housing member and an inlet tube extendsout of a side of the lid and the underlying lower housing member,adjacent the tip. Optionally, a length of large bore tubing may bereleasably or fixedly attached to the inlet tube and resides external tothe device.

A respective port formed by the aligned apertures of the front end ofthe lid and lower housing may be larger than the port formed by thealigned apertures on the right and/or left sidewall.

The cam may engage a shuttle to linearly translate the plunger. The cammay be pivotably attached to the lever about a fixed pivot point in thehousing under the shuttle. The trigger may include either a downwardlyextending hand grip with a manually operable trigger or an electronictrigger.

The curvilinear cam may have a downwardly extending segment or extensionthat contacts the trigger or is integral to the trigger and extendsbelow the fixed pivot point. The device may further include a torsionspring attached to a trigger anchor held adjacent the fixed pivot pointfor biasing the trigger to a return position. The downwardly extendingsegment or extension of the cam may include an arcuate open space abovethe fixed pivot point and a laterally extending and slidable pin lockmember that may be slidably received in the arcuate open space tothereby lock and unlock the trigger.

The trigger may include a manual lever that has a stroke distance thatis the same or no more than 20% longer than a plunger stroke distance ofthe syringe in the housing.

The infusion device may further include a syringe configured to be heldby the housing with at least the flange in the interior chamber of thehousing, a valve attached to the syringe and held by the housing, largebore tubing having an inner diameter greater than 3 mm and less than orequal to 6 mm and a length in a range of 4 feet to 10 feet, a small boretubing assembly with a length of small bore tubing having an innerdiameter of between 3 mm to 1 mm configured to attach to the exit portof the valve body, a clamp attached to the small bore tubing, and a Yconnector attaching adjacent ends of first and second lengths of thesmall bore tubing. The syringe may have a syringe body with a liquidchamber having a volumetric capacity in a range of 5 ml to 30 ml, thesyringe having an external surface with visual indicia of volume and aplunger that can slidably extend into and retract at least partiallyfrom the syringe body. The valve may include an axially extending valvebody with opposing first and second ends, the valve body including (a)an inlet tube residing between the first and second ends of the valvebody and (b) an exit port on the first end of the valve body. The secondend of the valve body may reside adjacent or inside the syringe and isin fluid communication with the liquid chamber. The large bore tubingmay have opposing longitudinally spaced apart first and second ends,with the first end of the large bore tubing attached to the inlet tubeand the second end comprising a spike. The first and second lengths ofsmall bore tubing may each have a free end of the tubing, away from theY connector, one with a male luer connector and one with a female luerconnector. The syringe with the attached valve, the large bore tubingattached to the inlet tube of the valve body, and the small bore tubingattached to the exit port of the valve body may all be held in a sterilepackage prior to use in the infusion device to thereby be provided in asterile and ready-to-use assembly.

The infusion device may further include a syringe held by the housing, adual check valve attached to a dispensing end of the syringe and influid communication with the liquid chamber of the syringe, and eitheror both: (a) a small bore tubing assembly with a length having an innerdiameter of between 3 mm to 1 mm configured to attach to an exit port ofthe dual check valve, a clamp attached to the small bore tubing, a Yconnector attaching adjacent ends of first and second lengths of smallbore tubing, the first and second lengths of small bore tubing eachhaving a respective free end away from the Y connector, one having amale luer connection and one having a female luer connector, optionallyfor a needleless valve configuration, or (b) a small bore tubingassembly with a length of small bore tubing having an inner diameter of3 mm to 1 mm configured to attach to an exit port of the dual checkvalve and having a male luer connection on an end of the small boretubing away from the end attached to the exit port. The syringe may havea syringe body with a liquid chamber having a volumetric capacity in arange of 5 ml to 30 ml.

The infusion device may further include a syringe held by the housing, adual check valve attached to a dispensing end of the syringe and influid communication with the liquid chamber of the syringe, and one ormore of the following: (i) a contrast agent tubing sub-assembly withfirst and second segments of inlet tubing, with at least one segmentincluding a length of large bore tubing, each of the first and secondsegments of inlet tubing having one end with a spike, the first andsecond segments connected by a two-way selector valve configured toattach to the inlet port of the inlet tube for a cardiology infusionprocedure; (ii) a length of small bore outlet tubing between the exitport of the dual check valve and comprising a pressure relief valve influid communication with the syringe; and (iii) first and second lengthsof large bore tubing, each comprising a clamp and a large bore spikeinserted/insertable into a corresponding first and second pouch ofliquid, where the first and second lengths of large bore tubing meet atan in-line filter adjacent a Y connector that merges into a single largebore inlet tubing segment attached to the inlet tube of the dual checkvalve to thereby allow a user to attach one pouch comprising blood orblood product to the first length of large bore tubing and anothercomprising an infusion liquid (optionally saline) to the second lengthof large bore tubing. The syringe may have a syringe body with a liquidchamber having a volumetric capacity in a range of 5 ml to 30 ml. Thedual check valve may include an axially extending primary body and aninlet tube with an inlet port residing longitudinally spaced apart froman exit dispensing port.

The infusion device may further include a syringe held by the housing,at least one pressure load cell in the housing coupled to the syringethat generates a signal associated with a measured pressure or forcebeing applied to the syringe by a user through the trigger, and aprocessor in communication with the at least one pressure load cellwhich is configured to determine a fluid pressure of a fluid dispensedbased on the force or pressure measured by the pressure load cell. Thefluid pressure may be determined based on the force or pressure measuredby the pressure load cell and a diameter of the plunger of the syringe.The syringe may have a syringe body with a liquid chamber having avolumetric capacity in a range of 5 ml to 30 ml. The syringe may have aplunger that can slidably extend into and retract at least partiallyfrom the syringe body.

The infusion device may further include a syringe held by the housing, avalve attached to the syringe and held by the housing, a pressure sensoror load cell in fluid communication with the syringe and/or an fluidintake or discharge flow path, and a user interface with a display incommunication with a processor. The syringe may have a syringe body witha liquid chamber having a volumetric capacity in a range of 5 ml to 30ml, the syringe having a plunger that can slidably extend into andretract at least partially from the syringe body. The valve may includean axially extending valve body with opposing first and second ends. Thevalve body may include (a) an inlet tube residing between the first andsecond ends of the valve body and (b) an exit port on the first end ofthe valve body. The second end of the valve body may reside adjacent orinside the syringe and is in fluid communication with the liquidchamber. The user interface may be configured to allow a user to selecta desired pressure limit associated with a type of fluid source(optionally an IV bag) attached to an inlet port of tubing attached tothe inlet tube of the valve.

The infusion device may be configured to disable the plunger of thesyringe when the determined fluid pressure of the fluid dispensedexceeds a defined limit.

The interior chamber may be sized and configured to releasably andserially interchangeably hold syringes of different volumes. Respectiveones of the serially interchangeable syringes of different volumes mayhave a common length.

Respective ones of the serially interchangeable syringes of differentvolumes may have a common stroke length. The stroke length may be adistance traveled by a respective plunger of the syringe through thesyringe body. The flange of each respective syringe of the seriallyinterchangeable syringes of different volumes may include at least oneof a common flange width, a common flange height, and a common flangethickness.

The infusion device may further include a processor held by the housing.The processor may be configured to correlate a volume of a respectivesyringe then held in the housing with a pressure applied to the triggerto determine a pressure of the fluid being dispensed through the outletport. The processor may direct the device to generate an audible and/orvisual alert when total fluid dispensed reaches a defined limit whichcan optionally be a user set limit.

The infusion device may further include a processor and at least onesensor held by the housing. The processor may communicate with the atleast one sensor to identify what syringe type and/or volume iscurrently held in the housing based on a radial extension of thesyringe.

The housing may include a tube retaining feature extending laterallyacross a width dimension of the housing perpendicular to longitudinaldirection of the housing adjacent a forward end portion of the housingconfigured to releasably hold a length of large bore tubing.

The tube retaining feature may include a cross-channel in a lowerportion of the housing extending from a right side of the housing to theleft side of the housing between the trigger and forward end of thehousing.

The tube retaining feature may include at least one retaining clampattached to lower portion of the housing and extending downwardlyconfigured to releasably hold a length of tubing.

The cam may include a downwardly extending lever segment that, in use,resides below the syringe and is attached to the trigger and thatrotates about a fixed pivot point. The downwardly extending lever mayinclude first and second segments that reside below the fixed pivotpoint that are configured to break responsive to an application of forceby a user that exceeds a defined force. The downwardly extending levermay include first and second segments that reside below the fixed pivotpoint that are configured to disengage with a resettable hinge inresponse to an application of force by a user that exceeds a definedforce.

The infusion device may further include an encoder in communication withthe syringe to provide dispensed volume information to a user.

The infusion device may further include a kit with first and secondsterile packages of components. The first sterile package may include asyringe held by the housing, the syringe having a syringe body with aliquid chamber having a volumetric capacity in a range of 5 ml to 30 ml,a dual check valve attached to a dispensing end of the syringe and influid communication with the liquid chamber of the syringe, and smallbore tubing having an inner diameter of between 3 mm to 1 mm configuredto attach to an exit port of the dual check valve, a clamp attached tothe small bore tubing, and a Y connector attached to the small boretubing. The second sterile package may include a syringe of painmedication (optionally lidocaine) for attaching to the Y connector fordispensing the pain medication to a user through the small bore tubing.

The infusion device may further include a kit with first and secondsterile packages of components used with the device. The first sterilepackage may include a syringe to be inserted into the housing, thesyringe having a syringe body with a liquid chamber having a volumetriccapacity in a range of 5 ml to 30 ml, a dual check valve pre-attached toa dispensing end of the syringe and in fluid communication with theliquid chamber of the syringe, and small bore tubing having an innerdiameter of between 3 mm to 1 mm configured to attach to an exit port ofthe dual check valve, a clamp attached to the small bore tubing, and a Yconnector attached to the small bore tubing. The second sterile packagemay include a first syringe of a pain medication (optionally lidocaine)and a second syringe of buffer (optionally sodium bicarbonate) eachconfigured to be in fluid communication with the Y connector to providea buffered pain medication to a user through the small bore tubing.

In some embodiments, an infuser system includes a housing configured tohold a syringe with a plunger, a shuttle in the housing configured toengage the plunger of the syringe, and a trigger including a lever heldby the housing. The lever rotates about a fixed pivot point under thesyringe. The lever includes a first segment and a second segment that,during normal operation, cooperate to linearly translate the shuttle ina first direction in response to actuation of the trigger and rotationof the lever about the fixed pivot point. One or both of the firstand/or second segment is configured to disengage and/or break responsiveto an application of a force to the trigger by a user that exceeds adefined force. The infusion system is configured to dispense fluid fromthe syringe responsive to actuation of the trigger. The defined force iscorrelated to be above a maximal desired pressure at which the fluid isdispensed from the syringe.

The defined force may be about 70 lbf, optionally between 70 lbf and 100lbf.

The first and/or second segment of the lever may include an aperturepositioned below the fixed pivot point and adjacent an outer edge of thelever. The aperture may have a first original configuration with a wallsurrounding the aperture that changes to a second deformed configurationwhere the wall separates about a portion of the aperture during useresponsive to the application of force by the user that exceeds thedefined force to thereby disengage and/or break the lever.

The aperture may be positioned to be within between 0.01 and 0.1 inchesfrom the outer edge of the lever. Optionally, the second segment of thelever may include a first material and a second material different thanthe first material.

The defined force may be defined so as to disengage and/or break thefirst and/or second segment of the lever when the pressure of the fluiddispensed from the syringe exceeds a pressure between 5.8 PSI to 325PSI.

The lever may include a cam with a slot residing above the firstsegment. The first segment may be pivotably connected to the secondsegment with a pivot pin below the fixed pivot point.

The first and/or second segment of the lever may be configured toreattachably disengage from each other. The device may further include aresettable hinge between the first segment and the second segment whichdisengages the segments when the user applies a force that is greaterthan or equal to the defined force.

The first segment may be pivotably connected to the second segment witha pivot pin below the fixed pivot point. The resettable hinge mayinclude a spring-loaded plunger that resides above the pivot pin thatcan laterally extend and retract to respectively engage and disengagewith an aligned recess. During operation of the infuser system thespring-loaded plunger may disengage from the recess when the userapplies the force that is greater than or equal to the defined force.

The infuser system may further include a restraint mechanism that can beselectively engaged to the resettable hinge. The restraint mechanism maybe configured to disable the resettable hinge such that the lowerportion is restricted from pivoting and the first and second segmentsremain operatively engaged even when the user applies the force that isgreater than or equal to the defined force.

The defined force may be defined so as to pivot the lower portion of thesecond segment of the lever away from the first segment of the leverwhen the pressure of the fluid dispensed from the syringe exceeds adefined pressure. The defined pressure may be between 5.8 PSI to 325PSI.

The first segment may be pivotably connected to the second segment witha pivot pin below the fixed pivot point. The resettable hinge mayinclude at least one magnet below the pivot pin.

The at least one magnet of the resettable hinge may include at least afirst magnet on the first segment and at least a cooperating secondmagnet on the second segment. The first and second magnets may beconfigured to magnetically couple during normal operation of the infusersystem and decouple when the user applies the force that is greater thanor equal to the defined force.

The at least one magnet may include at least one magnet on one of thefirst or second segments and a cooperating ferromagnetic and/or rareearth magnet on another of the first or second segments that areconfigured to magnetically couple during normal operation of the infusersystem and decouple when the user applies the force that is greater thanor equal to the defined force.

Some embodiments of the present invention are directed to a kit ofcomponents for a medical infusion for infusion devices and infusersystems. The kits include: a syringe having a syringe body with a liquidchamber having a volumetric capacity in a range of 5 ml to 30 ml, thesyringe having an external surface with visual indicia of volume and aplunger that can slidably extend into and retract at least partiallyfrom the syringe body; large bore tubing having an inner diametergreater than 3 mm and less than or equal to 6 mm and a length in a rangeof 4 feet to 10 feet, the large bore tubing having opposinglongitudinally spaced apart first and second ends; a valve with anaxially extending valve body with opposing first and second ends, thevalve body including (a) an inlet tube residing between the first andsecond ends of the valve body and (b) an exit port on the first end ofthe valve body; and a package holding the syringe pre-attached to thevalve body and the large bore tubing in a sterile condition separatefrom or pre-attached to the inlet tube to thereby provide components ina ready-to-use configuration for insertion of the syringe and valve intoan infusion device.

The inlet tube may be attached to the first end of the large boretubing. The second end of the valve body may reside adjacent or insidethe syringe and is in fluid communication with the liquid chamber. Theinlet tube may extend outward perpendicular to the axially extendingvalve body to be parallel with a laterally extending plane of the flangeof the syringe. Optionally, the flange may reside a distance between 3inches and 5 inches from an axially extending centerline of the inlettube. An axially extending centerline of the inlet tube may belongitudinally spaced apart a distance of 0.7 inches from an exit tip ofthe syringe body. Attached to the inlet tube, the large bore tubing maybe parallel to the flange and is oriented to position the volume indiciafacing upward.

It is noted that aspects of the invention described with respect to oneembodiment, may be incorporated in a different embodiment although notspecifically described relative thereto. That is, all embodiments and/orfeatures of any embodiment can be combined in any way and/orcombination. Applicant reserves the right to change any originally filedclaim or file any new claim accordingly, including the right to be ableto amend any originally filed claim to depend from and/or incorporateany feature of any other claim although not originally claimed in thatmanner. These and other objects and/or aspects of the present inventionare explained in detail in the specification set forth below.

BRIEF DESCRIPTION OF THE DRAWINGS

The previous summary and the following detailed descriptions are to beread in view of the drawings, which illustrate particular exemplaryembodiments and features as briefly described below. The summary anddetailed descriptions, however, are not limited to only thoseembodiments and features explicitly illustrated.

FIG. 1 is a cross sectional view of a delivery mechanism according to atleast one embodiment of the invention.

FIG. 2 is a side view of the delivery mechanism of FIG. 1 according toembodiments of the invention.

FIG. 3 is an isometric view of the delivery mechanism of FIGS. 1-2according to embodiments of the invention.

FIG. 4 is a side view of the delivery system of FIG. 1 in a closedposition, showing an exemplary non-binding dimensional measurementaccording to embodiments of the invention.

FIG. 5 is a side view of the delivery system of FIG. 1 in an openposition, showing another exemplary non-binding dimensional measurementaccording to embodiments of the invention.

FIG. 6 is a perspective view of a shuttle mechanism of FIG. 1 engagingthe operator-end of a syringe plunger according to embodiments of theinvention.

FIG. 7 is a perspective view of just the shuttle mechanism of FIG. 6according to embodiments of the invention.

FIG. 8A is a view of a delivery mechanism having a tracking wheel forcounting strokes of the trigger according to at least one embodimentaccording to embodiments of the invention.

FIG. 8B is a close view of the tracking wheel of FIG. 8A, taken alongthe plane of the wheel according to embodiments of the invention.

FIG. 8C is a close view of gear and pawl devices of the tracking wheelof FIGS. 8A and 8B according to embodiments of the invention.

FIG. 8D is a view of the gear and pawl devices of FIG. 8C shown in amore advanced counting position, the pawl shown engaged as whenadvancing the gear during forward advancement of the shuttle of thedelivery mechanism according to embodiments of the invention.

FIG. 8E is a view of the gear and pawl devices of FIGS. 8C and 8D, thepawl shown disengaged as when allowing the shuttle to retract accordingto embodiments of the invention.

FIG. 9 is a view of a delivery mechanism of FIGS. 1-3, having an addedpressure transducer and display according to embodiments of theinvention.

FIG. 10 is a view of the delivery mechanism of FIGS. 1-3, having andadded an encoder linked to the trigger to be used to determine triggerposition and optionally to calculate or confirm a volume of liquidinfused according to embodiments of the invention.

FIG. 11 is a cross sectional view of a powered delivery mechanism,according to at least one embodiment, having a powered shuttleadvancement for dispensing fluid from a syringe according to embodimentsof the invention.

FIG. 12 is a view of the motor and gear of FIG. 11, taken along theadvancement axis, shown engaging the shuttle according to embodiments ofthe invention.

FIG. 13A is a cross-sectional view of a mechanism for locking the lid ofthe delivery mechanism of FIGS. 1-3 according to embodiments of theinvention.

FIG. 13B is an isometric view of the locking mechanism of FIG. 13Aaccording to embodiments of the invention.

FIG. 14A is an isometric view of another locking mechanism for lockingthe lid of the delivery mechanism of FIGS. 1-3 according to embodimentsof the invention.

FIG. 14B is an isometric view of the locking mechanism of FIG. 14Aunlocked and the lid of the delivery mechanism shown as open accordingto embodiments of the invention.

FIG. 15 is a cross-sectional view of a delivery mechanism having afour-bar advancement system shown in a retracted position of its shuttlemechanism ready for dispensing fluid from a syringe according toembodiments of the invention.

FIG. 16 is a cross-sectional view of the delivery mechanism of FIG. 15A,shown with the four-bar advancement system shown in its shuttle-advancedposition after dispensing fluid from a syringe according to embodimentsof the invention.

FIG. 17 is a cross-sectional view of a delivery system with tubing andfluid bag attached for use according to embodiments of the invention.

FIG. 18 is a view depicting the delivery system of FIG. 17 in use in aclinical environment according to embodiments of the invention.

FIG. 19A is a top view of an example embodiment of a basic tubing setfor an infusion device according to embodiments of the invention.

FIG. 19B is an enlarged end view of the inlet tube relative to thesyringe valve according to embodiments of the invention.

FIG. 19C is a top view of the tubing set of FIG. 19A illustratingconnected adaptor tubing according to embodiments of the invention.

FIG. 19D is a top view of a set of components useful for treating arespective patient which can be provided in one or more packagesaccording to embodiments of the invention.

FIG. 20 is a schematic illustration of an example embodiment of salineand blood product administration tubing according to embodiments of theinvention.

FIG. 21 is a schematic illustration of an example embodiment of salineand contrast media tubing according to embodiments of the invention.

FIG. 22 is a side perspective view of an example embodiment of aninfusion device according to embodiments of the invention.

FIG. 23A is a top view of an example embodiment of a housing without alid according to embodiments of the invention.

FIG. 23B is a bottom view of an example embodiment of a lid of a housingaccording to embodiments of the invention.

FIG. 23C is a side view of an example embodiment of a housing without anattached tubing set according to embodiments of the invention.

FIG. 24 is an oblique front view of an example embodiment of a housingand lid according to embodiments of the invention.

FIG. 25 is a cross-sectional view of an example embodiment of a housingillustrating a latching mechanism according to embodiments of theinvention.

FIG. 26A is a schematic illustration of an infusion housing with atorsion spring and travel stop indicators of the housing according toembodiments of the invention.

FIG. 26B is a side view of the infusion device shown in FIG. 26Aaccording to embodiments of the invention.

FIG. 27A is a schematic illustration of an example embodiment of a pulselavage extension according to embodiments of the invention.

FIG. 27B is a schematic illustration of an example embodiment of thepulse lavage extension illustrated in FIG. 27A.

FIG. 28 is a schematic illustration of an example embodiment of anautomated pump schematic according to embodiments of the invention.

FIG. 29 is a schematic illustration of an example embodiment of amotorized enclosure with an internal fluid bag according to embodimentsof the invention.

FIG. 30 is a schematic illustration of an example embodiment of amotorized enclosure with an external fluid bag according to embodimentsof the invention.

FIG. 31 is an isometric view of an example embodiment of a compacthousing according to embodiments of the invention.

FIG. 32A is a side view of an example embodiment of a compact housing inthe open position according to embodiments of the invention.

FIG. 32B is a side view of the example embodiment shown in FIG. 32Aaccording to embodiments of the invention.

FIG. 33A is a schematic illustration of another example embodiment of acompact housing according to embodiments of the invention.

FIG. 33B is an enlarged view of an example embodiment for the compacthousing of FIG. 33A of a syringe flange according to embodiments of theinvention.

FIG. 33C is an enlarged view of an example embodiment for optionallocking tabs for the compact housing of FIG. 33A according toembodiments of the invention.

FIG. 33D is an enlarged view of an example embodiment for optionaldetents of the compact housing of FIG. 33A according to embodiments ofthe invention.

FIG. 34 is an isometric view of an example embodiment of an additionalcompact housing configuration according to embodiments of the invention.

FIG. 35A is a side view of an example embodiment of a lever of aninfusion device in operative position, according to embodiments of theinvention.

FIG. 35B is a side view of the lever shown in FIG. 35A, after breakingdue to exertion of a force above a defined amount, according toembodiments of the invention.

FIG. 36A is a side view of an example embodiment of a housing with thelever shown in FIG. 35A before the lever breaks according to embodimentsof the invention.

FIG. 36B is a side view of an example embodiment of the housing shown inFIG. 36A after the lever breaks according to embodiments of theinvention.

FIG. 37A is a side view of an example embodiment of a lever with aresettable hinge according to embodiments of the invention.

FIG. 37B is a side view of the lever shown in FIG. 37A with theresettable hinge, after disengaging, according to embodiments of theinvention.

FIG. 37C is a cross-sectional view of the example embodiment of thelever with the resettable hinge shown in FIG. 37A, according toembodiments of the invention.

FIG. 37D is a side view of an example embodiment of a lever with aresettable hinge with a magnetic latch according to embodiments of theinvention.

FIG. 37E is a side view of the lever shown in FIG. 37D with theresettable hinge, after disengaging, according to embodiments of theinvention.

FIG. 37F is a partial cross-sectional view of the example embodiment ofthe lever with the resettable hinge shown in FIG. 37D, according toembodiments of the invention.

FIG. 38 is a top view of an example embodiment of an outlet tubing setwith a pressure relief valve that can be connected to a valve, accordingto embodiments of the invention.

FIG. 39A is a partial schematic side view of an example embodiment of apressure monitoring system, according to embodiments of the invention.

FIG. 39B is a partial schematic side view of the pressure monitoringsystem of FIG. 39A shown in a locked position, according to embodimentsof the invention.

FIG. 40 is a side view of an example embodiment of an infusion devicewith a syringe inside a housing, according to embodiments of theinvention.

FIG. 41A is a top view of an example embodiment of an infusion devicewith a housing with integrated or attached inlet tubing managementfeatures, according to embodiments of the invention.

FIG. 41B is a side view the infusion device shown in FIG. 41A, accordingto embodiments of the invention.

FIG. 41C is a side view of an infusion device similar to that shown inFIG. 41A, according to other embodiments of the invention.

FIG. 42 is a side view of example syringe bodies with varying volumesbut with a constant stroke for infusion devices according to embodimentsof the invention.

FIG. 43 is a side view of a syringe such as those shown in FIG. 42,illustrated with the plunger shown in the fully depressed and fullyretracted (broken line) positions, according to embodiments of theinvention.

FIG. 44 is a front view of example syringe bodies with different sizesfor use in a common infusion device, according to embodiments of theinvention.

FIG. 45A is a partial schematic side view of an infusion device that canserially and interchangeably hold syringes with different volumes,according to embodiments of the invention.

FIG. 45B is a top view of the infusion device in FIG. 45A containing asyringe of a first size and a syringe detection sensor configurationaccording to embodiments of the invention.

FIG. 45C is a top view of the infusion device from FIG. 45A containing asyringe of a second size different from the syringe of the first sizeshown in FIG. 45B, according to embodiments of the invention.

FIG. 45D is a schematic view of a monitoring system for the infusiondevice of FIGS. 45A-45C configured to determine a size of a respectivesyringe, according to embodiments of the invention.

FIG. 46A is a side view of an infusion device incorporating anelectromechanical actuation member, according to embodiments of theinvention.

FIG. 46B is a side view of the infusion device of FIG. 46A with thetrigger extended, according to embodiments of the invention.

FIG. 47A is a side view of an embodiment of a handheld infusion deviceincorporating a motor, according to embodiments of the invention.

FIG. 47B is a side view of the infusion device of FIG. 47A in aretracted position, according to embodiments of the invention.

FIG. 48A is a side view of an embodiment of a handheld infusion deviceincorporating a linear actuator, according to embodiments of theinvention.

FIG. 48B is a side view of the infusion device of FIG. 48A in aretracted position, according to embodiments of the invention.

FIG. 49 is an isometric view of a container incorporating an infusiondevice, pain medication and an interosseous access system according toembodiments of the invention.

FIG. 50 illustrates exemplary operations for infusing fluid to a subjectaccording to embodiments of the invention.

DETAILED DESCRIPTION

These descriptions are presented with sufficient details to provide anunderstanding of one or more particular embodiments of broader inventivesubject matters. These descriptions expound upon and exemplifyparticular features of those particular embodiments without limiting theinventive subject matters to the explicitly described embodiments andfeatures. Considerations in view of these descriptions will likely giverise to additional and similar embodiments and features withoutdeparting from the scope of the inventive subject matters. Although theterm “step” may be expressly used or implied relating to features ofprocesses or methods, no implication is made of any particular order orsequence among such expressed or implied steps unless an order orsequence is explicitly stated.

Any dimensions expressed or implied in the drawings and thesedescriptions are provided for exemplary purposes. Thus, not allembodiments within the scope of the drawings and these descriptions aremade according to such exemplary dimensions. The drawings are not madenecessarily to scale. Thus, not all embodiments within the scope of thedrawings and these descriptions are made according to the apparent scaleof the drawings with regard to relative dimensions in the drawings.However, for each drawing, at least one embodiment is made according tothe apparent relative scale of the drawing.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this invention belongs. It will befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the specification andrelevant art and should not be interpreted in an idealized or overlyformal sense unless expressly so defined herein. Well-known functions orconstructions may not be described in detail for brevity and/or clarity.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a,” “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising,” when used in this specification, specify thepresence of stated features, steps, operations, elements, and/orcomponents, but do not preclude the presence or addition of one or moreother features, steps, operations, elements, components, and/or groupsthereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items. Like numberstypically refer to like elements throughout. In the figures, thethickness of certain lines, layers, components, elements or features maybe exaggerated for clarity. As used herein, phrases such as “between Xand Y” and “between about X and Y” should be interpreted to include Xand Y. As used herein, phrases such as “between about X and Y” mean“between about X and about Y.” As used herein, phrases such as “fromabout X to Y” mean “from about X to about Y.”

The term “about” means that the recited parameter can vary from thenoted value, typically by +/−20%.

The term “sterile” means that the noted device or material meets orexceeds defined medical guidelines (e.g., regulatory) of cleanlinesssuch as those required by the U.S. Food and Drug Administration (FDA)and is substantially (if not totally) without contaminants so as to besuitable for medical uses. In some embodiments, sterile devices ormaterials may be provided in a sterile package such as, but not limitedto, a flexible pouch.

The term “instructional media” refers to electronic and/or papermanuals, videos, user guides, or the like illustrating and/or describingoperation of the debridement tool and/or the spinal facet debridementsurgical procedure.

The term “large bore” refers to tubing or openings with an ID (innerdiameter) between greater than 3 mm and less than or equal to 6 mm,typically greater than or equal to 3.5 mm and less than or equal to 6mm. Large bore can be about 3.5 mm, about 4 mm, about 4.5 mm, about 5mm, about 5.5 mm, or about 6 mm. The term “small bore” refers to tubingor openings with an ID between greater than or equal to 1 mm and lessthan or equal to 3 mm, typically between greater than or equal to 2 mmand less than or equal to 3 mm.

The term “pain medication” refers to analgesics and/or anesthetics,including medications comprising lidocaine, prilocaine, benzocaine,mepivicaine, etidocaine, articaine, bupivicaine, procaine, tetracaine,and/or marcaine. In some embodiments, a medical buffering solution maybe added to pain medication to decrease pain experienced duringadministration of the pain medication. The medical buffering solutionmay include, for example, sodium bicarbonate, sodium hydroxide, calciumbicarbonate, magnesium oxide, potassium hydroxide, sodium carbonate,tris(hydroxylmethyl)aminomethane and the like.

The embodiments of the invention discussed herein may be used with bothhumans and animals. As such, the term “patient” refers to both human andanimal patients.

FIGS. 1-5 depict a system 10 to infuse fluid. The system 10 may operateto infuse fluid from a syringe 48 in response to input from a user. Insome embodiments, the syringe 48 may be serially interchangeable in thesystem 10. The system 10 may accept various sizes of syringes 48. Forexample, the system 10 can accept 5 ml, 10 ml, 15 ml, 20 ml, 25 ml, and30 ml syringes 48, though the present invention is not limited thereto.In some embodiments, the system 10 may be configured so as to allow theuser to interchange a first syringe 48 of a first size with a secondsyringe 48 of a second size, different from the first size, during useof the system 10. The syringe 48 can be integral to the system 10,affixed thereto or releasably attached.

The system 10 may also include a stationary grip 39 for the user tograsp the system 10 during operation. As shown in FIGS. 1-5, the system10 may include a trigger 37 accessible to the user while holding thegrip 39. The trigger 37 may be a manual/mechanical trigger 37 as shownin FIGS. 1-5 or may comprise an electronic trigger 37′ (i.e., FIGS. 11,47A) which allows a user to intake and dispense fluid from the syringe48. In some embodiments, the trigger 37 can rotate about a fixed pivotpoint 53.

The infusion device 10 can include a lever 52. The upper part of thelever 52U (FIG. 4) is in communication with and/or includes a lever 52containing a cam 52C which may have a closed cam path 52P that canchange the rotational motion of the trigger 37 into axial motion of theshuttle mechanism 56, which, in turn, holds the plunger 41. A pin 57 orother attachment member can be fixed to the shuttle mechanism 56 and cantravel along a track 52T in response to interaction with a cam 52C (FIG.4) of the lever 52. A return spring 55 can return the trigger 37 to anextended open position (FIG. 5) when firing is complete by actuation ofthe trigger 37 to the retracted position (FIGS. 1-4). The return spring55 can be connected close to the pivot point 53 on the lever 52 portionof the actuation trigger 37, and also to the housing 62 and can becontained within a stationary grip 39 of the housing 62. Trigger 37 isshown in a closed state in FIGS. 1 and 4. The shuttle mechanism 56 canhave a slot 64 which accepts the outer end of the syringe plunger 41.Slot 64 can be open at the top so a syringe 48 can be dropped in fromabove. The body of the syringe 48 can have a flange 40 which is held bya receiving slot 50 in the housing body (illustrated in FIG. 22). Thiscan hold the syringe 48 in place while the plunger 41 is actuated. A lid42 can pivot open and close about a fixed pivot 63, which allows accessfor the syringe 48 during loading, but protects the user from all movingparts during use. Lid 42 can be held down to the lower housing member162 with magnets or other attachments or locks. A number of differentfeatures including, but not limited to, magnets, detents, latches orother mechanisms may also be used to secure the lid 42 to the housing62. The lid 42 may contain a lid cavity 42C. An upper portion 52U (FIG.4) of the lever 52 can be configured to travel up and down a distance ofbetween about 1.25 inches and about 2.25 inches in the lid cavity 42Cduring the use of the housing 62. The lever 52 may have a strokedistance that is the same or no more than 20% longer than the strokedistance of the plunger 41. As illustrated in FIGS. 4 and 5, the lever52 may travel a stroke distance which may be a distance D1 to a distanceD2 from a given point on the stationary grip 39. In some embodiments,the stroke distance may be from 1.25 inches to 3.5 inches. A lock button24 can be moved transversely by the user. When moved to the lockedposition, the trigger 37 will be held in the closed position as shown.When the lock button 24 is moved to the unlocked position, the trigger37 is free to move unimpeded. This can be accomplished by a largediameter present on the lock button, which enters a large diametercircular cut-out in the trigger, locking the motion. When the lockbutton 24 is pushed to the “unlock” position, a smaller diameter in thelock button can align with the smaller diameter cut-out in the triggerto allow unimpeded motion. The syringe 48 can be connected to a dualcheck valve 31. The inlet 34 of the dual check value 31 can allow fluidfrom the fluid reservoir to enter the syringe 48 when the plunger 41 isretracted. The outlet 32 of the dual check valve 31 can allow highpressure fluid to exit the syringe 48 when the plunger 41 is forciblydepressed, and travel to the patient.

Suitable dual check valves are currently manufactured by a number ofsuppliers in the medical field, including companies such as BBraun (B.Braun Medical Inc., Bethlehem, Pa.) and Merit (Merit Medical Systems,Inc., Salt Lake City, Utah). Non-exhaustive examples of possible valvesinclude part numbers S5401086SN, S5401096SN, and S5069200N from BBraunand part numbers 500012002, 500012003, and 500012006 from Merit. Thesevalves provide a variety of different connection methods to the inlettubing, outlet tubing, as well as the syringe, including slip fit, luerfit, and tubing pocket fits. In some embodiments, the infusion systemcan be configured to reduce the resistance to flow on the exit and/orthe inflow of the fluid into the syringe. Embodiments of the inventioncan also or alternatively be configured to reduce the amount ofturbulent flow that occurs, especially when passing blood productsthrough the tubing. To that end, appropriate valve designs may beutilized such as to reduce the resistance to fluid flow. Check valvedesigns such as ball check, diaphragm check, duckbill, lift check and/orflapper valves may be used to create the dual check valve configurationfor operation. Ball and cage valves are another option which may be wellsuited for cycling blood. Additionally or alternatively, a split flappervalve can be used. The split flapper valve can be configured to pivotopen in the center and can allow the fluid to travel in a straighterpath, reducing resistance to flow. Alternatively or additionally, asplit valve with two pivot points located outside the main fluid travelchannel with the split located in the center of the channel can alsoallow the fluid to travel in a straighter path. Some valves mentionedabove have small bore openings when going through luer fittings andother connections to the syringe and or tubing. A syringe with a largebore opening may be used to directly integrate into at least one of thevalve housings, which may also reduce resistance to fluid flow and/ordecrease turbulent flow. In some embodiments, large bore openings mayalso be used in all fluidic inlet and/or outlets from the dual checkvalve.

FIGS. 6 and 7 depict a shuttle mechanism 56 having a slot 64 which canhold the operator end of the syringe plunger 41. Slot 64 can beconfigured such that the plunger 41 can be dropped into the shuttlemechanism 56 vertically from above, and then can actuate the plunger 41while remaining in place in the shuttle mechanism 56. A view of theshuttle mechanism 56 without the plunger 41 present is also shown.

The shuttle 56 can be approximately 1.5 inches in length, 1 inch inwidth, and 1 inch in height. The shuttle 56 can capture the syringeplunger 41 in a slot 64 positioned at its forward end, and can beconnected to the lever 52 at its rear end by a 0.25 inch diameter pin,which further slides within two 0.25 inch slots which guide the shuttle56 parallel to the long axis of the device. The shuttle 56 can have asmall groove just large enough for the plunger 41 of a 5 ml, 10 ml, 20ml or 30 ml syringe 48 to be dropped in from the top. In someembodiments, other syringe 48 sizes may be supported. The groove can besized to capture more than 50% of the syringe plunger 41. This can allowthe syringe 48 to be dropped in freely from the top, but can securelycapture the device during actuation. A similar groove can also presenton the housing 62, which can capture the body of the syringe 48, and canallow the shuttle 56, when moved back and forth, to actuate the syringe48.

In some embodiments, the volume of fluid dispensed from the syringe 48can be electronically or mechanically tracked. There are multiple waysto track the volume of fluid being infused. For example, a mechanicalcounting mechanism can be integrated into the housing 62, which cancount each full closure of the trigger 37. One embodiment of a mechanismis shown in FIGS. 8A-8E. A spring loaded pawl 81 can push a gear 84forward, at the completion of a stroke. The pawl 81 can push into a stop82 while in air, or when advancing the gear 84. When the shuttle 56 isbeing retracted, the pawl 81 can be allowed to rotate to clear gearteeth. The gear 84 can be connected to a dial wheel 85, with anindicator arrow 86 outside the housing 62, in a location visible to theuser. The user can determine the number of times the device has beenactuated by looking at markings 87 on the side of the housing. Anadditional set of gear teeth and ratchet can be incorporated into shaft83 to prevent the wheel from moving backwards inadvertently. In FIG. 8Athe dial wheel 85 can be in such a position that the indicator 86 ispointing at 0, which indicates the device has not yet been cycled. Awide variety of markings with corresponding gear sizes are possible.FIGS. 8C-8E show cross-sectional views. The user may also be able toreset the dial by pressing the dial down to bypass the additional gearteeth and ratchet and manually spinning the wheel to zero or anotherdesired location.

FIG. 9 shows a display 90 integrated into the housing. The display 90may show volume infused, number of a strokes completed, infusionpressure or other information to the user on a LCD screen, electronicink, or other screen 91. Buttons 92 may allow the user to choose setpoints, change units, and or reset the values displayed on the screen.In this configuration a pressure transducer 93 is shown in communicationwith the patient side of the tubing and connected to the display 90. Insome embodiments, a wired or wireless connection may be connected tothis display 90 from an encoder tracking housing movement, or aprocessor calculating multiple parameters. In some embodiments, thehousing may include an encoder in communication with the syringe, aprocessor in communication with the encoder. The processor may beconfigured to calculate a dispensed volume and provide the dispensedvolume to the display 90. In some embodiments, the processor may beconfigured to direct the device to generate an alert with a definedamount of fluid has been dispensed. In some embodiment, the buttons 92may allow the user to set a desired target dispensed volume amount. Insome embodiments, a priming amount of liquid can be electronicallydecremented from the dispensed volume or the user reset input can directthe processor to calculate the dispensed volume after a primingoperation.

FIG. 10 is a cross sectional view of a housing mechanism including arotary encoder. In this embodiment, an optical encoder wheel 75 can bemounted to the trigger 37. The sensor can be mounted on the housing andmay measure the location of the trigger 37, shuttle 56 and plunger 41 asthey move together. A linear encoder attached to the shuttle can beanother embodiment of this configuration. In this case the sensor canremain on the housing 62, but in a different location. Magnetic or othertypes of encoders can replace the optical encoders as alternateembodiments. The encoders can be connected electrically to a processorcapable of calculating the total amount of travel, and can display thatinformation to the user. The amount of travel can be used to calculate avolume of liquid infused. A zeroing button or other method of resettingthe display can allow the user to start or stop the count at any point.Alternately the user may select a desired amount of fluid to infuse andthe system may provide an auditory or visual alert when that level wasreached, or nearly reached.

FIG. 11 depicts a system 600 with a powered (i.e., motor driven)injection mechanism. A motor 151 can actuate a series of gears, depictedas a rack 155 and pinion 154 in the embodiment shown, however a numberof other gear combinations and configurations can be used, including aworm gear, a series of spur gears, planetary gears and/or bevel gears.The motor 151 is shown perpendicular to the motion of the shuttletravel, located in the grip 39. Other locations for the motor 151 caninclude being parallel to the motion of the shuttle, above or below thetrack. The motor 151 can also be located proximal to the shuttle, at theback of the housing, or in front. The rack 155 is attached to a shuttlemechanism 156. The shuttle mechanism 156 has a track 14 which holds theplunger 41 of the syringe 48, and allows for axial motion of the plunger41. Multiple pins 157 can hold the shuttle mechanism 156 in position asthe rack and pinion gears turn. The motor 151 may be either powered by acable plugged into a standard outlet or a battery pack as depicted as152. A trigger 37′ can be an electronic control button or switch. Thecontrol button 37′ can allow the user to control the flow of fluid.Additional buttons can be added if the user desires additional controlinputs, such as pressure or volume targets or limits. A processor suchas a CPU 158 can be used to control the actions of the motor 151, recordperformance, and/or modify performance based on additional inputs suchas pressure transducers. An encoder or encoders can be integrated intothe motor 151, to calculate the position of the shuttle mechanism 156 atall times. Alternately a linear encoder may be placed on the shuttle156, with the sensor mounted on the housing 62. FIG. 12 depicts a closerview of the rack and pinion mechanism as shown from a rear view.

In FIG. 13A, a cross section view is shown of the lid and a detent lever127 to secure the lid 42 to the housing. A detent 125 on the lid 42 canhave an interference fit with a groove on the housing 126. The length ofthe detent lever 127 and amount of interference with the housing canallow the force to be tuned to a low enough level appropriate for a userto open the lid 42 when desired, but remain high enough to keep the lidin place during normal use. Ledges 128 can allow the user to gainadditional leverage when releasing the detent 125 from the housing 62.FIG. 13B is an isometric view of the same mechanism. The detent 125 canbe on a single side of the housing 62, or on both sides.

Alternately, other locks can be used, e.g., a two piece lockingmechanism can allow the user to twist a knob to the “locked” position tohold the lid in place, and can be twisted to an “unlocked” position whenthe lid 42 can be released. FIG. 14A shows this mechanism with a lockknob 135 twisted into the locked position. FIG. 14B shows this mechanismwith a lock knob 135 twisted into the unlocked position, and the lid 42in an open position such that a syringe 48 may be loaded. Lock knob 135can engage with lip 136 to hold the lid 42 in place. Additional featuresadded to the housing 62 may limit the movement of the lock knob 135 suchthat the user may be able to find the unlocked and locked positions, andavoid over or under rotation. Magnets or other methods may also be usedto secure the lid 42.

FIG. 15 depicts a mechanical system with a four bar linkage system. Theactuation lever 172 can be connected to the lever 52 with a cam path52P, and a cross link 171. Cross link 171 can be connected to a fixedpivot point and a second cross link. The cam path 52P can rotate about asecond fixed point 173. FIG. 16 depicts the same system in a closedconfiguration.

FIGS. 17 and 18 depict a system in use in a clinical environment. Thepatient is shown lying on a table in FIG. 18. Tubing 100 can connectedfrom a fluid bag to the patient, and the housing 62 is shown in theuser's hand in FIG. 18. In this case the fluid is delivered through thepatient's tibial plateau through an intraosseous port. A cross sectionalview in FIG. 18 shows an illustration of the fluid perfusion through thetrabecular bone of the tibial plateau. Other configurations forconnections to the patient may include, but are not limited to, usingthe system to connect directly to a peripheral catheter. Additionally,the system can be used for wound irrigation or other methods wheredirect connection to the patient is not required. The system shown inFIGS. 17-18 generically represents any of the above describedembodiments.

FIG. 19A is a top view of an example embodiment of a basic tubing set10S for an infusion device 10 according to embodiments of the invention.FIG. 19B is an enlarged front view of the inlet tube 34 relative to thesyringe 48 valve. An exemplary tubing set 10S which includes asingle-spike inlet tubing set 100 is described below. A 10 ml syringe 48(or other sizes, such as 5 ml, 20 ml, or 30 ml, not shown) can bedirectly connected (e.g. pre-attached) to a dual check valve 31,comprising two valves, an inlet valve 34 and an output valve 32. Thesyringe 48 has a syringe body 48B, a plunger 41 and a flange 40. Largebore inlet tubing 100 with a length of about 2-12 feet can be attacheddirectly to the inlet valve 34, typically about 5 feet. In someembodiments, for example, lesser lengths or greater lengths may be used.Examples of bore tubing 100 lengths include 2.5, 3, 3.5, 4, 4.5, 5, 5.5,6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12 feet, or greater.In some embodiments, the ID of the large bore inlet tubing 100 can beabout 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, or about 6 mm. Insome particular embodiments, the ID is about 4.3 mm. The other end ofthe inlet tubing 100 can be attached to an inlet spike 102, which iscompatible with standard IV fluid bags, among other containers, andincludes a finger grip 101, and inlet spike connection 103. The outputof the dual check valve 32 may be or comprise a male luer connection,which can allow connection to a multitude of currently available tubing.The inlet portion 34 of the dual check valve 31 can be lined up to beparallel with the indicia 38 on the syringe body 48. The indicia 38 mayprovide visual indicia of a volume of the syringe 48. In someembodiments, the visual indicia 38 of the volume of the syringe 48 maybe a marking or other indicator in a graduated scale on an outer surfaceof the syringe 48. The alignment of the indicia may allow the housing 62to orient the inlet tubing 100 and/or inlet valve 34 such that theindicia 38 may be visible to the operator during use, to allow precisecontrol of the amount of fluid infused into the patient. The inlet tube34T may be parallel and oriented to extend outward from either the rightor left side. In the embodiment shown, the inlet tubing 100 is orientedto extend perpendicularly outward from the housing to the right. If theprovider is standing on the right side of the patient and the fluid bagis near the patient's feet, this configuration can minimize clashing orlooping of the inlet tubing 100 with the other activities beingperformed on the patient. Additional asymmetries may be present on thesyringe body 48, the check valve 31, or tubing 100 to assist the userwhen aligning the syringe 48 into the housing 62. Without this alignmentfeature, it may be possible for the user to place the indicia 38 on thesyringe 48 such that they are not visible during use. This may gounnoticed during set-up, and the user may be reluctant to disassemblethe system in order to make the indicia 38 visible if set-upincorrectly. Because this may be a usability concern, and usability istypically a concern for both the FDA and the International Organizationfor Standardization (ISO) when getting clearance for the use of medicaldevices, facilitating and/or forcing proper alignment during insertionof the syringe 48 as part of the design can avoid/address this issue.

Precisely controlling the distance between the syringe body 48 and theinlet tube 34T with the inlet tubing 100 may allow for the housing 62 toencapsulate at least a sub-segment of the inlet tube 34T attached to theinlet tubing 100 and/or valve tube holding the inlet tubing, and preventthe assembly of the device in an incorrect orientation. In theconfiguration shown, the inlet tube 34T with the inlet tubing 100 can beat a distance D of between about 0.5 inches and about 0.9 inches fromthe end of the syringe. That is, an axially extending centerline of theinlet tube 34T can be a distance D of between about 0.5 inches and about0.9 inches from the discharge end of the syringe 48 which is attached tothe check valve 31. In some embodiments, the distance D is about 0.7inches. Also shown in FIG. 19A, the inlet tube 34T with the inlet tubing100 can be at a distance L of between about 2 inches and about 5 inchesfrom the flange 40 of the syringe 48, typically between about 3.25inches and 4.25 inches. That is, an axially extending centerline of theinlet tube 34T can be a distance L of between about 2 inches and about 5inches from the flange 40 of the syringe 48. In some embodiments, thedistance L is about 3.75 inches. This configuration may additionallyprevent, inhibit or reduce rotation of the tubing 100 during use, whichcan allow the user to avoid the clashing or catching of the inlet tubing100 while performing other tasks related to the resuscitation of thepatient.

To facilitate easier connections to the IV or IO needle, a set ofadaptor tubing 109 may be used. This set of adaptor tubing 109 may beabout 6 inches to 12 inches in length, in the configuration shown here,although longer lengths may also be used. In order to allow theinjection of other fluids beyond the fluid in the previously mentionedIV fluid bag, a second set of adaptor tubing 109 may also bepre-attached or provided separately to connect to the output port 32 ofthe dual check valve 31. The adaptor tubing can include a female luerconnection 104, which may be a needleless female luer connection,connected via a tubing pocket connection 106 to small bore tubing 109.The female leur 104 may be connected directly to the output 32 of thecheck valve 31. The small bore tubing 109 may connect directly to a maleluer 112, via another tubing pocket connection capable of withstandinghigh pressures. This male luer connection 112 can connect directly to anIV or IO placed into a patient. Alternatively, as shown in this figure,a Y connector 108 may be used. The Y connector 108 may contain aneedleless female luer connection 107. The Y connector 108 can allowdirect connection to a syringe containing other fluids which may beinjected into the patient, or may also be used for a gravity feed IVline. FIG. 19C is a top view of the tubing set of FIG. 19A illustratingadaptor tubing 109 connected to the output 32 of the check valve 31.

One or more thumb clamps 110 may be present to stop the flow of fluid.If needed, the set of adaptor tubing 109 described above may be removedfrom the infusing tubing, and remain with the patient when transferringfrom an ambulance to a hospital, or other situations.

The tubing set 10S can be provided in a ready-to-use kit 10K. The kit10K can include at least one package that holds the tubing set 10S in asterile condition. The kit 10K can include instructional media 8. Theinstructional media 8 can be provided either electronically and/or inpaper form that facilitates proper use, assembly, and/or training of thetubing set 10S. The media can include a suitably descriptive titleand/or label identifying the content as instructions/training materialfor the tubing set 10S. Electronic instructional media 8 can include avideo or electronic instructional manual that can be shown on a display.The instructional media 8 can be provided via the Internet such as at ahosted internet portal/site, via an APP for a smart phone, computer,electronic notebook or tablet and the like, typically via the use of anicon with defined functionality as is known to those of skill in theart. Paper instructional media 8 can include a paper user manual orbooklet such as an instructional manual showing proper usage of thetubing set 105.

FIG. 19D is a top view of a set of components useful for treating arespective patient which can be provided in one or more packages,typically in a single external package 10K holding multiple internalsterile kit packages 10K1, 10K2. As shown, the set of components caninclude at least one pre-filled syringe 901, which can optionallycomprise first and second separate pre-filled syringes 901,911 ofdifferent substances along with a tubing set 10S having or attachable tothe infusion syringe 48 according to embodiments of the invention. Insome embodiments, the set of components can be provided as a kit 10Kthat can comprise a first sterile package which provides the tubing set10S and at least one other (i.e., a second) sterile kit package with theat least one pre-filled syringe 901 and/or 911 comprising medicationthat can be administered to a respective patient with the tubing set10S. The at least one pre-filled syringe 901 can comprise a localanesthetic. Where more than one pre-filled syringe 901, 911 is included,the second pre-filled syringe 911 can comprise a buffering agent thatcan be mixed in situ with the local anesthetic and delivered via outlettubing of the tubing set 10S to a patient.

The pre-filled syringes 901, 911 may be provided in one package within asingle kit 10K, or may be provided in separate packages which areexternal to, separate from, or attached to a package of the kit 10Kholding the tubing set 10S. In some embodiments, the kit 10K maycomprise one sterile package (indicated by the broken line perimeterabout the set of components) which includes both the syringes 901, 911and the tubing set 105. In some embodiments, the kit 10K may comprise afirst sterile package 10K1 with the tubing set 10S and a separate secondsterile package 10K2 with a pre-filled syringe 901 for local painrelief, optionally with the buffering agent pre-filled syringe 911 inthe second package 10K2 or in a third package holding only the bufferingagent syringe 911. One or more pre-filled syringes 901 can compriselidocaine, or other local anesthetic, and may be packaged in a singlekit package 10K1 along with the tubing set 105. In some embodiments, thekit 10K can provide a kit package 10K1 for the tubing set 10S and aseparate at least one kit package 10K2 containing one, or both,pre-filled syringes 901, 911, at least one of which is a pre-filledsyringe 901 containing a local anesthetic, such as lidocaine, and atleast one of which is a pre-filled syringe 911 containing a bufferingagent, such as sodium bicarbonate.

FIG. 20 is a schematic illustration of an example embodiment of salineand blood product administration tubing according to embodiments of theinvention. When transferring blood into a patient, additionalconfigurations of tubing sets 200 may be used. In the configurationshown, tubing set 200 is capable of transferring blood and bloodproducts to a patient. Two inlet spikes 202 are connected to two fluidbags, 201 and 212. One bag 201 can contain blood or blood products,while a second bag 212 contains saline or other similar fluids. As usedherein, blood products can include products derived from blood includingplatelets, plasma, plasma derivatives, cryoprecipitated antihemophilicfactor, and red blood cells, though the present invention is not limitedthereto. In order to selectively isolate each bag, two clamps 203 and211 can be provided, one on each inlet line 217 and 218. These clamps203, 211 may be roller clamps which can both limit and fully shut offthe tubing, and/or a thumb clamp which can only be fully opened or fullyclosed. The inlet tubing 217 and 218 may be large bore tubing, typicallyabout 4.3 mm inner diameter. The two inlet tubes 217, 218 may be joinedat a Y connection 204, which may be configured to have reduced or norestrictions to flow. The fluid may then pass through a filter 205 andmay continue through a common inlet tube 216 to the dual check valve 31.In the configuration shown, a large bore connection 208 with little orno narrowing (e.g., a constant inner diameter connection) may be presentbetween the dual check valve 31 and the syringe 48. The fluid can exitthe outlet 215, which is a male luer connection. This connection may beconnected to adaptor tubing 109 (FIG. 19A) previously described.

This tubing 216 can be primed with saline by connecting one inlet spike202 to a bag of saline 212 or similar fluid, and opening all clamps andallowing fluid to flow through the entire system, using both gravity andcycling the syringe plunger 41. After the system is (fully) primed, thesecond inlet spike 202 can be placed into a bag containing bloodproducts 201. The user can then select either the blood or, for example,saline to infuse, and open the appropriate clamp, 203 or 211. If rollerclamps 203 are used, the user may set the clamps such that a tunablemixture of both blood and, for example, saline is pulled into the inlettubing 216. Once the bag of blood products 201 is fully emptied the bagof saline or other fluid 212 may be used to flush the remaining bloodproducts present in the tubing 216. A new bag of blood 201 and/or salineor other similar fluid may be attached to the system via a steriletechnique, if desired by the user.

FIG. 21 is a schematic illustration of an example embodiment of salineand contrast media tubing according to embodiments of the invention. Amanually-activated syringe 48 with a connection for saline and contrastmedia can be used in interventional cardiology procedures to administercontrast media when performing heart surgery through the use ofcatheters. In this embodiment, contrast tubing 250 can include two largebore inlet tubes 217 and 218. In another embodiment, inlet tube 217 maybe small bore tubing. Inlet tube 217 can be connected to a container ofcontrast media 229 via a vented spike 225. Contrast media is typicallyprovided in hard glass bottles of about 150 ml. A second inlet spike 202can connect to a fluid bag filled with saline or other products 230. Thetwo inlet tubes 217,218 can connect at a two way selector valve 226.This two-way selector valve 226 can allow the user to select between thetwo different fluids when infusing into the patient. In someembodiments, the two-way selector valve 226 can reside to the side ofthe dual check valve 31. In some embodiments, the two-way selector valve226 can be present on the side of the housing 62, within closer reach ofthe actuation mechanism (e.g. trigger 37, FIG. 22) on the housing 62.This configuration can have a further length of inlet tubing which canfluidly couple the two-way selector valve 226 to the dual check valve31. The dual check valve 31 can be connected to a syringe 48, which canbe between 30 ml and 5 ml in size. At the exit of the dual check valve31 a pressure transducer 227 can be present to measure the pressure ofthe fluid. Smaller diameter (smaller than the inlet tubing) exit tubing228 can transfer the fluid to a needleless Y valve 231, and then to amale luer connection 232. The male luer connection 232 can be used toconnect to a cardiac catheter.

FIG. 22 is a side perspective view of an example embodiment of aninfusion device according to embodiments of the invention. The inletportion 34 of the dual check valve 31 can be lined up to be parallelwith the volume indicia 38 on the syringe body 48. This alignment allowsthe housing 62 to orient the tubing set such that the volume indicia 38is visible to the operator during use, to allow precise control of theamount of fluid infused into the patient. The inlet portion 34 may beoriented to extend out of either the right or left side. In theconfiguration shown, the inlet tubing is oriented to the right. Thesyringe 48 fits in slots in the housing 62, with the plunger 41 capturedin the shuttle 56. Additional asymmetries may be present on the syringebody 48, the dual check valve 31, or tubing to assist the user whenaligning the syringe 48 into the housing 62. Without this alignmentfeature, it may be possible for the user to place the volume indicia 38on the syringe 48 such that the volume indicia 38 are not visible duringuse. As noted above, this may go unnoticed during set-up, and the usermay be reluctant to disassemble the system in order to make the indicia38 visible. Because this is a usability concern, and usability istypically a concern for both the FDA and ISO when getting clearance forthe use of medical devices, facilitating or forcing proper alignmentduring insertion of the syringe 48 as part of the design can addressthis issue.

In some embodiments, precisely controlling the distance between thesyringe body 48 and the inlet tube 34T with the inlet tubing 100 canallow for the housing 62 to encapsulate at least a sub-segment orportion of the inlet tube 34T with the inlet tubing 100, and can inhibitor prevent the assembly of the device from resulting in an incorrectorientation. In the configuration shown, the inlet tube 34T with thetubing 100 is at a distance of between 0.5 inches and 0.9 inches fromthe end of the syringe 48. This configuration can also inhibit orprevent rotation of the tubing during use which allows the user to avoidclashing or catching of the inlet tubing 100 while performing othertasks related to the resuscitation of the patient.

FIG. 22 shows the check valve 31 of the tubing set 10S loaded within thehousing 62, and the lid 42 open. A dual check valve assembly 31 with aninlet 34 and outlet 32 is connected to a syringe 48. The connectionbetween the syringe 48 and check valve 31 may be a male/female luerconnection, or it may be a large bore custom connection. The inlet 34 isaligned to be parallel with the flange 40 of the syringe 48, andpositioned such that the volume indicia 38 are visible when viewed fromabove, and the inlet tubing 100 extends out to the right. Alternateconfigurations include having the inlet tubing 100 extending out to theleft, or at the bottom of the housing 162. There can be specific cutouts33, 46 in the housing 62 to receive the syringe 48 and check valve 31.One housing cutout 33 (to be clear “cutout” refers to an aperture oraccess opening) in the sidewall can encircle inlet tubing 34, a secondcutout 46 in the tip can reside about outlet 32. The cutouts can beentirely in the lower housing 162, entirely in the lid 42, or providedas pairs of cutouts in the lid 42 and lower housing 162 that face eachother. The sidewall aperture for the inlet tube 34T can be circular(typically semi-circular in the upper and lower housing members) and canbe on a right and/or left side. In some embodiments, the apertures canbe other shapes, such as, for example, rectangular, triangular, oval,and the like. The sidewall aperture can be larger or smaller than thetip aperture for outlet 32.

There can be corresponding cutouts 45, 46 in the lid 42 which, togetherwith the lower housing 162 cutouts, can completely encircle the inlettube 34T and the valve outlet 32, and can ensure the desired orientationof the inlet tubing 100, indicia 38 and syringe 48 when assembled. Therecan be additional features in both the lower housing 162 and lid 42 toreceive and secure the syringe 48. A slot 50 in the housing 62,typically the lower housing 162, can receive the flange 40. A circularcutout 35 can be sized and configured to receive the connection betweenthe check valve body 31 and syringe 48. There can be correspondingcutouts in the lid 42 to receive these two features as well. As shown,the lid 42 can have latch features 47 which secure the lid 42 to thehousing 62 via latch points 36. When latched, the lid 42 can hold thesyringe 48 securely in place in one orientation, and also can protectand orient the check valve 31. The lid can prevent rotation of thesyringe 48 by trapping the flange 40. The latch 47 can be released by auser when desired by squeezing the two latch extensions 51simultaneously, allowing the latch 47 to release the corresponding latchpoints 36. The latch extensions 51 can be visually evident to the userby one or more features. Shown in FIG. 22 is a scalloped cut in the lid42 at the location of the latch extension 51, and two downwardlyextending slots 44. The slots 44 can serve a second purpose, to reducethe bending force required to release the latches. The lid 42, can bevisually transmissive, typically transparent, and may have a highlypolished window 43 which may allow easy visualization of the syringe 48and its contents during use. The syringe 48 can be activated by moving atrigger 37, while holding a grip 39. The trigger 37 can be connected viaa cam path 52P to a shuttle 56, which can actuate the plunger 41.

FIG. 23A is a top view of an example embodiment of a housing 62 withouta lid 42 according to embodiments of the invention. FIG. 23B is a bottomview of an example embodiment of the lid 42 of the housing 62. FIG. 23Cis a side view of an example embodiment of a housing 62 without anattached tubing set. These illustrations show the features that interactwith and restrain the syringe 48, check valve 31, and inlet tubing 100during use. As shown in FIG. 23A, the receiving slot 50 for the syringeflange 40 can be seen in the housing 62. Support ribs 193 located on thelid 42 can also serve to locate and restrain the syringe flange 40.Flats present on both the receiving slot 50 and support ribs 193 serveto prevent rotation of the syringe flange 40. Adjacent to this slot 50is a circular recess 48C for the body of the syringe 48. Latch points 36can also be seen in this view, as well as the cutout 35 that receivesthe syringe tip. A chamber 31C surrounds the dual check valve 31 and canprovide protection and orientation guidance. This chamber 31C can havethree exits, syringe neck or tip cutout 35, inlet cutout 33 and exitcutout 46, which can allow the syringe tip, dual check valve inlet 34and dual check valve outlet 32 to pass through. A midline of the inletcutout 33 may be a distance L from the receiving slot 50. In someembodiments, the distance L may be between about 2 and about 5 inches,typically between about 3.25 inches and 4.25 inches. In someembodiments, L is 3.75 inches. Some or all of same features can belocated on the lid 42 as well. Shuttle 56 can move back and forth tomove the syringe plunger 41 during use. The syringe plunger 41 can fitinto receiving slot 64, and the shuttle 56 may be moved by the lever 52,which can transfer movement from the user's hand. A cam path 52P on thelever 52 can transfer force through a glide pin bushing 190B, into aglide pin 190, and then into the shuttle 56. A fixed pivot 63 can allowfor rotation of the lid 42 through a pivot point 63P.

In this embodiment, syringe tip cutout 35, receiving slot 50, and thesupport ribs 193 are the main points of contact which can mechanicallyrestrain the tubing set 10S during use.

FIG. 24 is an oblique front view of an example embodiment of a housingand lid according to embodiments of the invention. In this obliqueisometric view the opening for the inlet valve 33, opening for dualcheck valve exit 46 and cutout 35 for syringe tip are visible from adifferent angle, without the tubing present.

FIG. 25 is a cross-sectional view of an example embodiment of a housingillustrating a latching mechanism according to embodiments of theinvention. The lid latch 47 can overlap engagement catch 60 such that avertical force or side force will not inadvertently open the lid 42.Latch extensions 51 can allow users to press on the sides of the latchesto release. Side slots 44 may be used to decrease the force required torelease the latch 47. The tabs 163 which can hold the syringe flange 40in place can also be seen in this view. The plunger 41 of the syringe 48is also visible in the view. These can be supported by a support rib 62Sin the housing 62. A side view of the pin lock 61 is also visible.

FIGS. 26A and 26B show side views with an embodiment containing atorsion spring 157 instead of an extension spring. FIG. 26B is anotherside view of the torsion spring 657 and travel stop indicators of thehousing 62. As shown, the torsion spring 657 can have one anchor point654 on the lever 52, and another point on the handle 656. The centralloop of the torsion spring 657 is shown outside of the trigger pivot 53,but it may also be centered around the trigger pivot 53. It may also beuseful for the user to get audible and/or tactile feedback when thetrigger 37 reaches full open and full closed position. There aremultiple ways to accomplish this. An embodiment illustrated in thesefigures is the use of small tabs 655, 652 which can interfere with theactuation trigger. The rectangular tabs can be stiff, but can allowbuckling at a certain amount of deflection, this buckling can provideboth an audible and tactile feedback. One tab can indicate full open 655or full closed positions 652, or any other desired position within therange of travel of the actuation trigger 37. Other detent designs oralternatives may also be used to indicate these positions. Twoconfigurations are shown in these figures: full open (FIG. 26B) and fullclosed (FIG. 26A). In the full open position, the full open tab 655 isshown in the deflected state, and the torsion spring 657 is shown in thefully compressed state. In the full closed position, the full closeddetent 652 is shown deflected and the torsion spring 657 is partiallycompressed.

In some embodiments, a cutout 651 for a lock, such as lock 24illustrated in FIG. 1, can facilitate locking of the actuation trigger37.

FIG. 27A is a schematic illustration of an example embodiment of a pulselavage extension according to embodiments of the invention. FIG. 27B isa schematic illustration of an example embodiment of the pulse lavageextension illustrated in FIG. 27A. A pulse lavage system 275 may beattached to an IV bag and can be actuated by the dispenser housing 62. Afemale luer connection 277 can be compatible with the dual check valveoutlet port 32. This can be connected by either flexible or rigidextension tubing 276 to fluidly couple the dual check valve 31 to theexit nozzle 279. The exit nozzle 279 includes a gradually narrowingopening configured to accelerate fluid to a high velocity at exit, toassist with lavage of tissue. The shape of this exit nozzle 279 may be asimple circular opening or an oblong oval shape, depending on userdesire. A protective nose cone 278 can prevent splash back from exitingthe target area. The handle of the device can be squeezed, which canforce water or other sterile fluid through the exit nozzle 279,resulting in a high pressure flow. The high pressure flow can bedirected at a wound requiring debridement. The trigger 37, 37′ can berepeatedly cycled to refill automatically through the attached IV bag,connected to the inlet tubing via a spike (not shown).

FIG. 28 is a schematic illustration of an example embodiment of anautomated pump schematic according to embodiments of the invention.

Other embodiments contemplate a motorized version of the infusion system1100, utilizing a syringe 48 and tubing 100, but the plunger 41 is movedlinearly by the action of a motor rather than manually. In someembodiments, the tubing set may be identical to the previously disclosedtubing set 10S (FIG. 19A), having an inlet spike 102, large bore tubing100 about 5 feet in length, a dual check valve 31 and a syringe 48(e.g., having a volume between 5 ml to 30 ml), which may or may not beconnected to extension tubing. In some embodiments, the tubing set mayhave much shorter inlet tubing 1113 (0.5 feet-3 feet) and the inlettubing may be large bore, or may be traditional smaller bore tubing. Inother embodiments, two bags of fluid may be connected to a singlesyringe pump, with a Y joint and clamps to selectively control which bagprovides fluid at any one time.

A motor pack 1101 may be used to actuate the plunger 41 on the syringe48. The motorized system 1100 can have a slot 1102 for retaining thesyringe 48, and an asymmetric orientation to ensure the tubing isproperly oriented when placing for use. The syringe 48 can be held in avertical position to facilitate the elimination of air bubbles while thesystem is being primed. The syringe 48 can be actuated by a motor linkedby gears to create linear motion of the plunger 41. The motor output candrive an actuator 1103 up and down an actuator track 1114. The motoroutput may be controlled with several different control methods. In oneembodiment the motor can be displacement controlled such that the motortorque output can be adjusted continuously to achieve a known fluiddelivery rate. In another embodiment the motor may be current controlledsuch that it applies a known torque which generates a constant vacuumpressure and constant output pressure. In this case, the fluid infusionrate can vary, but the user can know that fluid is being infused at aknown pressure, and can know if the line is blocked or not placedproperly in the patient. It may also be possible to vary the torqueapplied so that the vacuum pressure created by motor retracting thesyringe 48 can be at a different set point than the output pressure,created by the motor advancing the syringe 48. It may be advantageous toallow user selection of the desired output pressure, while maintaining asingle vacuum pressure for maximum refill rate.

When using the motorized device the user can insert the inlet spike 1115into a bag of fluid 1112 (saline, blood products, or other necessaryfluid). The syringe 48 can be placed into the slot 1102 on the motorizedsystem 1100. In one embodiment, the bag 1112 can be placed with theoutlets pointing down in a traditional manner. In another embodiment,the bag of fluid 1112 can be placed with the spike 1115 facing upwardsin the motorized system 1100, which can allow the user to purge the airfrom the system while all components were secured into the system. Thesystem may have a sensor which detects the presence of a syringe 48loaded into the slot 1102. They system may also have an RFID 1116,barcode, or other information on the body of the syringe which canprovide information to the motorized system 1100 about the type oftubing inserted. The lid, lids, or other retaining features, can beclosed to secure the fluid bag 1112 and the syringe 48. The lid, lids orother retaining features can have sensors which detect the properclosure of the system. Once the system detects that a certain tubing sethas been properly secured, lights 1119 can illuminate the fluid bag 1112to assist in the visual identification of any air bubbles present in thebag. A “purge” button may be depressed, which can cycle the plunger 41at a slow and low torque until the user determined that all air had beenremoved from the fluid bag 1112, and the user can then release the purgebutton. Lights 1120 can then illuminate the vertical syringe 48. Theuser can again depress the purge button 1131 until all air bubbles areeliminated from the syringe 48 and any attached tubing. The tubing canthen be connected to the patient, and infusion can begin.

In some embodiments, the fluid bags 1112 may be hung outside themotorized system 1100, and the entire unit placed on a stand near thepatient, or hung from an IV pole near the patient.

FIG. 29 is a schematic illustration of an example embodiment of amotorized enclosure with an internal fluid bag according to embodimentsof the invention. FIG. 30 is a schematic illustration of an exampleembodiment of a motorized enclosure with an external fluid bag accordingto embodiments of the invention.

In one embodiment, the user may select a known infusion rate, and/or aknown infusion volume in the input screen 1130, and press the “infuse”button 1132. In another embodiment, the user can manually hold theinfuse button 1132 down in order to keep fluid flowing.

In some embodiments, a user may manually select a desired input pressureand total infusion volume in the input screen 1130 and press the infusebutton 1132. In a fourth embodiment, the user may select the type ofaccess present on the patient, such as IV, IO, central line, and thenselect the size of the appropriate access type (i.e. IV—20 gauge, orCentral line—4 French). In this case, the computer (e.g., at least oneprocessor) can select an appropriate input pressure based onpreprogrammed set points which correspond to each access type. While thesystem is infusing a display screen 1130 may indicate one or more of thefollowing: total fluid infused, current infusion pressure, currentinfusion rate, average infusion rate, patient access type and sizeselected, tubing type present in system, among other pertinentinformation.

Other embodiments may include the use of a counter that automaticallytracks the amount of fluid infused and operates with a “setpoint” 1133that provides an audible and visual alarm when the desired setpoint isreached. A “reset” button 1134 may also be used to re-zero the counter,if some fluid was used for priming or other purposes that did not reachthe patient. A display 1130 showing the setpoint and current amountinfused, next to a set of up/down buttons for the setpoint 1133 and areset button 1134, can provide this functionality.

In some embodiments, a motorized enclosure can receive power from abattery pack 1137 and/or a power connector 1138. The enclosure mayinclude a stand 1135 and/or a cover 1136.

Another configuration may have fewer components and have a smallerprofile. FIG. 31 is an isometric view of an example embodiment of acompact housing according to embodiments of the invention. FIG. 31 showssystem 299. This system can include a syringe 48 and dual check valve31. Other two-valve systems may be used instead of a dual check valve31. The syringe 48 can have a flange 40, and a plunger 41. The plunger41 can have a feature at the distal end with a cross bar 365 and asecond cross bar 366, held together by two connecting ribs 358. Thesefeatures and/or components can create a bracket 354 with an openingwhich can allow a curved actuation member 352 to move the plunger 41linearly in and out, as a result of a rotational movement of actuationlever 353 generated by the user grabbing loop trigger 37. The cross bars365, 366 can be cylindrical to allow sliding with minimal friction whensliding against the actuation member 352. This configuration caneliminate the need for a separate piece acting as a shuttle. The crossbars 365, 366 may be alternately constructed of, for example, alubricious plastic, a plastic core with a metal sleeve on the exterior,a metal rod surrounded by a plastic exterior, and/or a solid metalpiece.

The actuation lever 353 can be connected via a pivot point to the rigidgrip 39. A torsion spring 355 can bias the actuation lever 353 to theopen position. The torsion spring 355 may be covered by a torsion springcover 368 to keep contamination out of the torsion spring, or thetorsion spring may be exposed. Alternately, or additionally, a leafspring may be used to bias open the actuation lever 353. The leaf springmay connect to the bottom of the loop trigger 37 and also the bottom ofthe rigid grip 39, and contain a joint near the pivot point created bythe grip 39 and actuation lever 353. The rigid grip 39 can becontinuously connected to a holding mount 363, which can have areceiving slot 364. The receiving slot 364 may be sized to receive thesyringe flange 40. The receiving slot 364 and syringe flange 40 may havean asymmetry present to force the user to assemble the housing andtubing assemblies together in a single orientation. There may be arotating tab or other locking feature which can trap the syringe 48inside the holding mount 363 when the locking feature is deployed by theuser. The rigid grip 39 may also have an extension 367 which allows stoppins 359, to provide a consistent stopping point for the actuation lever353. The location of the stop pins 359 can be correlated with a desiredsyringe volume. The stop pins 359 can also be used as a pivot point forthe housing.

FIG. 32A is a side view of an example embodiment of a compact housing inthe open position according to embodiments of the invention. FIG. 32B isa side view of the example embodiment shown in FIG. 32A according toembodiments of the invention. These figures show detailed views of thetorsion spring 657. A protrusion of the rigid handle 658 can form thepivot point for the actuation lever 353. A first leg 656 of the torsionspring 657 is anchored in the pivot protrusion 658, and a second leg 654is anchored in the actuation lever 353. The torsion spring 657 biasesthe actuation lever 353 into the open position. In both of these viewsthe extension 367 and stop pins 359 are not shown.

FIG. 33A is a schematic illustration of another example embodiment of acompact housing according to embodiments of the invention. The outercover 370 can have holes 371 which receive the stop pins 359. The cover370 can pivot about these pins 359, and this can allow the user to placethe syringe 48 into the receiving slots 364 when the cover 370 ispivoted open, and can capture and hold the syringe 48 in place whenclosed. Locking tabs 372 or other features can be used to hold the outercover 370 in place. FIG. 33C is an enlarged view of an exampleembodiment for optional locking tabs 372 for the compact housing of FIG.33A according to embodiments of the invention. The locking tabs 372 maybe located near or on the holding mount 363. The outer cover 370 may beremoved entirely if desired for the user for greater access, or forcleaning between procedures through a variety of methods. The user maypry apart the outer cover 370 at the holes 371, which can allow thecover 370 to be removed from the stop pins 359. FIG. 33D is an enlargedview of an example embodiment for optional detents 373 of the compacthousing of FIG. 33A according to embodiments of the invention. In theseembodiments, the holes 371 may have channels with detents 373, which canallow the user to pull the outer cover 370 off when pivoted to the openposition. FIG. 33A also shows a torsion spring cover 368.

FIG. 33B is an enlarged view of an example embodiment for the compacthousing of FIG. 33A of a syringe flange 40 according to embodiments ofthe invention. FIG. 33B shows one possible asymmetry 372 which may bepresent in the syringe flange 40, and can be used to control orientationduring use. A corresponding mating feature can be present in thereceiving slot 364.

FIG. 34 is an isometric view of an example embodiment of an additionalcompact housing configuration according to embodiments of the invention.This configuration can have a loop trigger 37 and grip 39. The grip 39can be part of a housing 304. The housing 304 can include two halveswhich may be sealed together via a seal 303. The shuttle 300 is shown onthe exterior of the housing 304. As in other configurations the shuttle300 can have a receiving slot 314 which receives the plunger 312 of asyringe 313. However the shuttle 300 can be connected by a cylinder 301to the driving mechanism within the housing 304. The cylinder 301 can besealed by an o-ring 302 or other component which can prevent or reducewater and other fluids from entering the housing 304. The syringe flangecan have a feature which includes leg extensions 311 and placement tabs310. The placement tabs can be configured to fit into receiving tabs 309present on the exterior of the housing 304. The receiving tabs 309 canhold the syringe 313 in place during use, and the leg extensions 311 canprovide a natural boundary when the shuttle 300 is moving linearly tocycle the syringe plunger 312. The user can drop the syringe 313vertically into both the receiving slot 314 and receiving tabs 309before use. A pin lock 306 may be used to hold the loop trigger 37 andactuation lever 353 in a desired position, which can result in theshuttle 300 being pre-aligned with the plunger 312. A variety ofpreviously disclosed actuation mechanisms may be used to actuate theshuttle motion.

FIG. 35A is a side view of an example embodiment of a lever 52 of aninfusion device in operative position, according to embodiments of theinvention. The lever 52 engages the shuttle mechanism as describedabove. FIG. 35A depicts the lever 52 with a narrow segment of material753 having a defined width dimension X measured from an outer perimeterof the lever 52 to a line drawn tangent to an aperture 700. Thedimension X of the narrow segment of material 753 may range from 0.01inches to 0.15 inches though the present invention is not limitedthereto. The narrow segment of material 753 may extend between an uppersegment of the lever 52 and a lower segment 752 in or attached to thelever 52 which can disengage, break, and/or deform if an input forcegreater than a defined threshold is applied by a user. This force cancorrelate to an infusion pressure provided by the infusion device andthe disengagement, breaking, and/or deformation of the lower segment 752may inhibit overpressure of the fluid delivery by the infusion device.The greater than desired force can be above 10 lbf, typically above 50lbf, 60 lbf, 70 lbf, or 80 lbf, though the present invention is notlimited thereto. In some embodiments, the force at which the lever 52can disengage, break, and/or deform may be defined so as to limit thepressure at which fluid is delivered by the infusion device to below adefined pressure from 5.8 PSI to 325 PSI, typically 5.8 PSI, 10 PSI, 50PSI, 100 PSI, 200 PSI, 300 PSI, or 320 PSI, though the present inventionis not limited thereto. The lower segment 752 can be integral to thelever 52 or can be attached to the lever 52. In some embodiments, thedimension “X” of the narrow segment of material 753 is associated withan upper aperture 700 positioned under the pivot point 53. A secondaperture 701 may also serve to hold the lever 52 in place in thehousing, but may not participate in determining the force fordisengaging, breaking, and/or deforming the lower segment 752 of thelever 52. Also illustrated in FIG. 35A, the lever 52 can attach ordefine the trigger pivot 53, the return spring anchor point 654, and/orthe pin lock cutout 651. When the user applies a greater than desiredamount of force to the infusion device via the trigger 37, the segmentof material 753 adjacent the upper aperture 700 can fracture, and thelower segment 752 of the lever 52 may extend rearward relative to itsintact configuration during normal operation as a result of the undueinput force. Though the lever 52 is described as having a segment thatcan break, it will be understood by those of skill in the art thatbreaking of the lever 52 may include other types of structuraldisengagement, deformation and/or derivatives thereof that render thelever 52 with a diminished ability to operate the shuttle of thehousing.

FIG. 35B is a side view of the lever 52 shown in FIG. 35A, afterbreaking due to exertion of a force above a defined amount, according toembodiments of the invention. FIG. 35B depicts the lever 52 after aninput force has been exceeded a defined threshold value. The lowersegment 752 of the lever 52 extends more rearward relative to its intactconfiguration during normal operation, and the narrow segment ofmaterial 753 near upper aperture 700 has separated. In some embodiments,this separation may deform or otherwise alter the aperture 700 of FIG.35A to define a deformation zone 700 f in the lever 52. The thickness ofdimension X can be varied as desired to increase or reduce the force atwhich the lower segment 752 of the lever 52 disengages, breaks, and/ordeforms. In some embodiments, when the lower segment 752 of the lever 52disengages, breaks, and/or deforms, this action can provide a tactileresponse to the user. This allows the user to detect the overpressurecondition of the undue applied force without direct visualization, suchas in loud or distracting environments. Additionally, when disengaged,broken, and/or deformed, the lever 52 will no longer travel through thefull range of linear stroke motion, providing another tactile and visualsignal to the user that the infusion device has exceeded the forcethreshold.

In some embodiments, the dimension X of the narrow segment 753 may beapproximately 0.07 inches in an aluminum lever 52 which is approximately0.12 inches thick, though the present invention is not limited thereto.This configuration may result in a break-away force of approximately 70lbf. This break-away force can be tuned greater or lesser depending onthe desired function of the device. The break-away force may becontrolled using only dimension X if desired. Additionally, the materialthickness, material type or aperture 700 location may also be varied asdesired. The breakaway force can be checked through finite elementmodeling (FEA). In some embodiments, the break-away force may be tunedrelative to the output pressure of the fluid exiting the infusiondevice, rather than, or in addition to, the input force. Input force andoutput pressure may be linearly correlated, and can be calculated asdesired. It will be understood that a break-away force may include forcewhich only deform or otherwise alter the lever 52 or a segment attachedthereto and that a full breakage is not required to achieve theobjectives of the present invention.

FIG. 36A is a side view of an example embodiment of a housing 62 withthe lever 52 shown in FIG. 35A before the lever 52 breaks according toembodiments of the invention. FIG. 36B is a side view of an exampleembodiment of the housing 62 shown in FIG. 36A after the lever 52 breaksaccording to embodiments of the invention. These figures illustrate thebreakage of the lever 52 of FIGS. 35A & 35B as viewed when assembledwith a trigger 37 and housing 62. The connectors through upper aperture700 and lower aperture 701 that can hold the trigger 37 onto lever 52are visible in this view.

FIG. 37A is a side view of an example embodiment of a lever 52′ with aresettable hinge 701 according to embodiments of the invention. FIG. 37Bis a side view of the lever 52′ shown in FIG. 37A with the resettablehinge 701, after disengaging, according to embodiments of the invention.FIG. 37C is a cross-sectional view of the example embodiment of thelever 52′ with the resettable hinge 701 shown in FIG. 37A, according toembodiments of the invention. In some embodiments, the lever 52′ mayinclude a lower segment 706 that can disengage without permanent damagethereto. FIGS. 37A & 37B illustrate an example embodiment of theresettable lever 52′ in a normal and disengaged position, respectively.In some embodiments, the resettable lever 52′ may include an uppersegment 708 and a lower segment 706 under pivot point 53, which can be aprimary pivot point. In some embodiments, the lower segment 706 can beattached to the upper segment 708 via a secondary pivot point 700′,which may allow the lower segment 706 to disengage if a defined force isexceeded. The lower segment 706 may normally be held rigidly in placerelative to the upper segment 708. In some embodiments, the lowersegment 706 may be held rigidly in place relative to the upper segment708 by two spring loaded ball plungers 705 which form a detent. The ballplungers 705 may seat into two recesses 707 which can allow purchaseagainst the upper segment 708, during normal use of the lever 52′. Asecondary pivot pin 709 may extend through both the upper segment 708and the lower segment 706, through the secondary pivot point 700′. Theamount of force required to disengage the lower segment 706 can bedependent on the spring force of the ball plungers 705, and the amountof interference with the recesses 707. If the defined force is exceeded,a user may return the lower segment 706 to be rigidly connected to theupper segment 708 of the lever 52′, by pulling the lower segment 706outward. The edges of the upper segment 708 may be chamfered or radiusedto allow the force used to reset the lower segment 706 to be lower thanthe force required to disengage the lower segment 706. The force atwhich the lower segment 706 will disengage may be above 10 lbf,typically above 50 lbf, 60 lbf, 70 lbf, or 80 lbf, though the presentinvention is not limited thereto. In some embodiments, the force atwhich the lower segment 706 will disengage may be defined so as to limitthe pressure at which fluid is delivered by the infusion device to belowa defined pressure from 5.8 PSI to 325 PSI, typically 5.8 PSI, 10 PSI,50 PSI, 100 PSI, 200 PSI, 300 PSI, or 320 PSI, though the presentinvention is not limited thereto. In some embodiments, a metal loop maybe positioned by the user such that that no movement may be possiblearound the secondary pivot point 700′. This may allow the user to usethe device at greater pressures in urgent situations, and then return tonormal use as desired. In some embodiments, fixation devices may also beused instead of ball plungers 705 to rigidly hold the lower portion 706of the lever 52′ to the upper portion 708. In some embodiments, aresettable hinge 701 with a fixed detent, or pairs of magnets, may beused instead of, or in addition to, ball plungers 705. Those of ordinaryskill in the art will appreciate that additional configurations toachieve the resettable hinge 701 of the lever 52′ may be possible ascontemplated by the present invention.

FIG. 37D is a side view of an example embodiment of a lever 52″ with aresettable hinge 701′ with a magnetic latch according to embodiments ofthe invention. FIG. 37E is a side view of the lever 52″ shown in FIG.37D with the resettable hinge 701′, after disengaging, according toembodiments of the invention. FIG. 37F is a partial cross-sectional viewof the example embodiment of the lever 52″ with the resettable hinge701′ shown in FIG. 37D, according to embodiments of the invention. Insome embodiments, the resettable hinge 701′ may include at least onemagnet within a part of the lever 52″ which secures an upper segment708′ to a lower segment 706′. Thus, the upper segment 708′ of the lever52″ may releasably engage the lower segment 706′ of the lever 52″ viamagnetic force. In some embodiments, the magnetic force may be appliedby an upper magnet 714 that may be connected to the upper segment 708′of the lever 52″ and a lower magnet 715 that may be connected to thelower segment 706′ of the lever 52″. Upper segment 708′ and/or lowersegment 706′ may include fastening means for elements of the housing,such as, for example, screw holes 716 and 717. A return spring, such astorsion spring 157 illustrated in FIG. 26A may be connected to the lever52″ via attachment points, such as spring attachment hole 718. When inuse, the upper segment 708′ and the lower segment 706′ of the lever 52″may remain connected via the magnetic force so as to pivot the lever 52″about the pivot point 53, which may be a primary pivot point, inresponse to user input. When a force exceeding a defined force isapplied to the lever 52″, the lower segment 706′ may disengage from theupper segment 708′ of the lever 52″. The lower segment 706′ may pivotabout the secondary pivot point 700″, and the upper segment 708′ may nolonger move in response to user input to stop the plunger of the syringefrom further movement and thereby stop further liquid delivery from thesyringe. FIG. 37E depicts the lower segment 706′ after separation fromthe upper segment 708′. The desired force to achieve this breakaway maybe tuned by varying the composition, diameter, thickness and/orseparation distance of magnets, such as magnets 714 and 715, connectedto the upper and lower segments 708′/706′ of the lever 52″. Though twomagnets are illustrated in FIGS. 37D and 37E, other configurations ofmagnets are possible without deviating from the invention. In someembodiments, a magnet 714 or 715 can be attached to one of the lower orupper segment 706′/708′ and the other segment 708′/706′ may be metal. Insome embodiments, a single magnet may be used between two steel plates(or other metal) to increase the separation force.

In some embodiments, the location of a magnetic element may be adjustedto increase or decrease the lever between the magnetic element and thesecondary pivot point 700″. Moving the magnets further from thesecondary pivot point 700″ may decrease the magnetic force required tomaintain the resettable magnetic hinge 701′. In some embodiments, a rareearth magnet and/or ferromagnetic material may be used to generate theforce required. In some embodiments, neodymium magnets may be used togenerate the force required. In some embodiments, the defined force atwhich the resettable magnetic hinge 701′ will disengage may be 100 lbfin order to limit the pressure in the syringe to approximately 100 PSI.If the magnets 714/715 are located 0.75 inches from the secondary pivotpoint 700″, and the center distance of the input force is 0.25 inchesfrom the secondary pivot point 700″ a magnetic force of 33 lbs isrequired. FIG. 37F shows a partial cross section view of the secondarypivot 700″, and the upper 708′ and lower 706′ segments of the lever 52″.Those of ordinary skill in the art will appreciate that additionalconfigurations to achieve the resettable hinge 701′ of the lever 52″ maybe possible as contemplated by the present invention.

FIG. 38 is a top view of an example embodiment of an outlet tubing set100 with a pressure relief valve 710 that can be connected to a valve31, according to embodiments of the invention. The tubing set 100 may besimilar to the tubing set 100 illustrated in FIG. 19A with the additionof the pressure relief valve 710. The pressure relief valve 710 maylimit the fluidic pressure which can be applied to the patient. In someembodiments, the pressure relief valve 710 may open to release fluidsbeing dispensed through the output tubing when pressure as determined atthe pressure relief value 710 exceeds a defined limit. In someembodiments, the pressure relief valve 710 may reduce or block fluidsbeing dispensed through the output tubing when pressure as determined atthe pressure relief value 710 exceeds a defined limit. The pressurerelief valve 710 may be connected directly to the outlet of the dualcheck valve 31, and there may be a male leur connection 711 on theoutlet side of the pressure relief valve 710. In some embodiments, theremay also be a length of small bore outlet tubing between the outlet ofthe dual check valve 31 and the pressure relief valve 710. The pressurerelief valve 710 may be set as desired to a clinically relevantpressure. Some “high pressure” infusers have a maximum pressure of 300or 320 PSI, and this may be used as a set point. Other set pressurepoints may also be chosen as desired. One example of a pressure reliefvalve which may be used in some embodiments includes the “T” pressurerelief valve provided by Halkey-Roberts Corporation of Saint Petersburg,Fla. In some embodiments, the pressure relief value 710 can bemechanically combined with a pressure transducer, such as the pressuretransducer 93 of FIG. 9 and/or the pressure transducer 227 of FIG. 21.

In some embodiments, a user may choose to override the pressure reliefvalve 710 if required by the clinical situation. A screw-on cap, aretaining lever, or other device may be actuated by the user tomechanically close the pressure relief valve 710. This may allow theuser to continue to apply greater pressures if needed. This override mayrequire positive action from the user in order to override the pressurelimit.

FIG. 39A is a partial schematic side view of an example embodiment of apressure monitoring system 815, according to embodiments of theinvention. FIG. 39B is a partial schematic side view of the pressuremonitoring system of FIG. 39A shown in a locked position, according toembodiments of the invention This pressure monitoring system 815 mayallow a user to know the pressure being applied to the pressuremonitoring system 815 at various points during infusion, and may be usedto alert the user if a pressure limit is exceeded. In some embodiments,the pressure monitoring system 815 may lock out the infusion system sogreater than desired fluidic pressures cannot be applied to the patient.A load cell 800 may detect the force applied between the syringe flange40 and the housing 62, when a trigger, such as trigger 37 of FIGS. 36A &36B, is being actuated and fluid is being forced into or out of thesyringe 48. The trigger may apply a force through a series of linkagesto the shuttle 804 which moves the plunger 41. Fluid pressure may begenerated when a force is applied to the plunger 41 and the flange 40resists movement. The syringe flange 40 may impart axial force withinthe housing 62. The housing 62 may impart some vertical forces on thesyringe 48 through the length of the syringe 48, and some incidentalfrictional forces in the axial direction. Some embodiments may use thedistal tip of the syringe 48, or other parts of the syringe 48, plunger41, or valve assembly to measure these forces.

The axial force on the syringe flange 40 can be translated into apressure measurement, if the diameter of the syringe plunger 41 is known[Pressure=(Measured Force)/(Area of Plunger)]. The force may be measuredby a button load cell or other load cell 800 mounted between the housing62 and a mounting bracket 806. There may be one centrally mounted loadcell 800 below and mid-line on the syringe 48, two load cells placed atlateral sides of the mounting bracket 806, or more than two load cells800 placed in multiple locations. If two or more load cells 800 areused, the total measured force may be summed between all load cells 800.A cut-out 807 present in the housing 62 may provide a defined channel tokeep the mounting bracket 806 in-line with the load cells 800. In someembodiments, bushings, linear bearings, and/or other methods may be usedto reduce friction between the mounting bracket 806 and the housing 62.The load cell 800 may be a button load cell, which registers compressiveforces as the plunger 41 is depressed. In some embodiments, the loadcell 800 may be screwed into both the housing 62 and the mountingbracket 806, which may allow both tension and compression to bemeasured.

In some embodiments, a display 802 on the outside of the housing 62 mayshow the current pressure being applied to the fluid in the syringe 48.The display 802 may be similar to the display 90 illustrated in FIG. 9and may include a screen and user interface input such as the screen 91(which can be a touchscreen) and/or input buttons 92 of FIG. 9. Thedisplay 802 can display information including, but not limited to,maximum pressure, current pressure, average pressure, and/ornot-to-exceed pressure. The not-to-exceed pressure threshold may be setby the user and/or pre-programmed. Some examples of pre-programmedlimits, based on the size of the IV/IO attached are included in Table 1.This data is correlated with a 10 ml syringe.

TABLE 1 Pressure Alarm Limits Upper Lower Alarm Alarm IV/IO access LimitLimit size (PSI) (PSI) 15G IO needle 55.8 0.0 16G 40.0 9.5 22G 94.0 21.122G Central 110.6 30.0 LineA user may input an IV/IO size using an input and/or display similar tothe display 90 (FIG. 9), or by other input means such as, for example, atouchscreen with graphics. The system 815 may then select an alarm limitbased on the table above. If no IV/IO is selected the system 815 mayproceed without alarm limits, or may be locked to prevent any motion ofthe syringe plunger 41 until an IV/IO size is selected. In someembodiments, the not-to-exceed pressure threshold may be the upper alarmlimit as illustrated in Table 1. In some embodiments, the upper alarmlimit may be a percentage of the not-to-exceed pressure, such as 80% or90%.

The display 802 may an independent display 802. In some embodiments, thedisplay 802 may be multi-purpose and show volume of fluid transfusedand/or other metrics. The display 802 may be connected to the load cell800 via a processer 809 to translate the signal from the load cell 800.The processer 809 may be connected to a speaker 803, which may beprogrammed to sound an audible alarm when the pressure reaches orexceeds the not-to-exceed threshold. In some embodiments, the audiblealarm may be generated when the pressure reaches or exceeds a levellower than the not-to-exceed threshold, such as the lower alarm limitillustrated in Table 1. The processor 809 may be connected to a pivotpoint lock 801, a solenoid and/or other device which extends or retractswith force into the trigger to prevent the user from being able toimpart any additional force to the trigger and plunger until the forceis reduced below the not-to-exceed threshold. In some embodiments, aplunger lock 805 may be advanced by a solenoid or other mechanism andprevent any subsequent plunger 41 movement once a not-to-exceed pressureis reached. The plunger lock teeth 817 may be angled to slightly retractthe plunger 41 as the plunger lock 805 engages. This may reduce theapplied pressure as the lock is applied. Locking mechanisms may bereleased by the user pressing a release button 810, which mayelectronically signal the processer 809. In some embodiments, theprocessor 809 may release a lock mechanism after a pre-determined amountof time has elapsed.

FIG. 40 is a side view of an example embodiment of an infusion devicewith a syringe 48 inside a housing 712, according to embodiments of theinvention. In this view, the flange 40 of a syringe 48 and the syringeplunger 41 may be within a housing 712. The housing 712 may have asmaller axial extent that encloses the plunger 41 and flange, while thesyringe body 48 may be external. A plunger 41 which interfaces directlywith the lever 52 is depicted here, but other configurations of plunger41 and lever 52 may be used. In some embodiments, the housing 712 may bepre-loaded with the syringe 48, and may be locked or sealed so as toinhibit, prevent, or make the housing 712 difficult to open by the user.This may reduce set-up and/or the potential for use errors, because thesystem requires little assembly by the user. The syringe 48 may beattached to a dual check valve 31. A spike 102 may be connected to largebore inlet tubing 100, which leads to the inlet of the dual check valve31. Outlet tubing 109 may lead to a pressure relief valve 710. Alsoshown is a thumb clamp 110 and male leur outlet 111. Additional tubingfeatures such as a needleless Y valve may also be incorporated in someembodiments of the configuration. As shown in this embodiment, thesyringe body 48 may be external to the housing 712 and directly visibleto the user. As described above, other embodiments may include a housing712 which encapsulates the entire syringe body 48, and may have a clearcanopy to view the syringe body 48. In some embodiments, this canopy maynot be able to pivot open during use. Other embodiments may incorporateor integrate the body of the syringe 48 directly into the housing 712,such that the syringe body 48 and the body of the housing 712 may be asingle integrated piece. This may further reduce assembly time and/ormanufacturing costs.

FIG. 41A is a top view of an example embodiment of an infusion devicewith a housing with integrated or attached inlet tubing managementfeatures 750, according to embodiments of the invention. FIG. 41B is aside view the infusion device shown in FIG. 41A, according toembodiments of the invention. FIG. 41C is a side view of an infusiondevice similar to that shown in FIG. 41A, according to other embodimentsof the invention. In some embodiments, the tubing management feature 750may comprise a retaining feature. The inlet tubing management feature750 may be a semi-circular cross-channel or opening 751 which has alarge enough diameter to receive inlet tubing 100, but a small enoughopening 751 to retain the inlet tubing 100 during normal use. The inlettubing 100 may deform as it is pressed into the tubing managementfeature 750 and may remain trapped until the user pulls it free. Thisopening 751 may be used if the inlet tubing 100 is exiting to the right(as illustrated in FIG. 41A), but the user may wish to connect the inlettubing 100 to a bag of fluid which is to the left of the user. Thetubing 100 may be looped underneath the housing 62, and held in place bythe tubing management feature 750. The tubing management feature 750 mayorient the inlet tubing 100 in such a way as to generate a bend 100B inthe tubing 100. The bend 100B in the tubing 100 may be a distance Sifrom a centerline of an outlet tubing 109 of the housing 62. In someembodiments, the distance Si may be between about 2 and about 10 inches.The bend 100B in the tubing 100 may be a distance S2 from an edge of thehousing 62. In some embodiments, the distance S2 may be between about 1to about 9 inches. The tubing management feature 750 may orient theinlet tubing 100 so as to cross the housing 62 at a distance S3 from aninlet portion 34 of the dual check valve 31. In some embodiments, thedistance S3 may be between about 1 to about 8 inches. In someembodiments, the tubing management feature 750 may be a clamp 755 heldunder the housing 62 as illustrated in FIG. 41C.

FIG. 42 is a side view of example syringe bodies with varying volumesbut with a constant stroke for infusion devices according to embodimentsof the invention. FIG. 42 depicts two different syringes bodies thathave the same overall length, but which hold varying volumes of fluids.The syringe body 48′ may have indicia which cover a fixed length L₁ 831.The inner radius can have multiple sizes such as, for example, R₁ 825 orR₂ 826. The thickness (T_(F)) 832, the height (not shown), and width(W_(F)) 827 of the flange 40′ may be fixed, as well as the location ofthe flange (L_(F)) 828 relative to the most proximal indicia mark. Thediameter of the exit (D_(E)) 830 may also remain constant, and may besized to receive a female leur fitting. The exit may also be a fixeddistance (L_(E)) 829 from the most proximal indicia. To allow the strokelength to remain constant irrespective of the volume of the syringe 48′,a radius R of the syringe body 48′ can follow the following formula:R=√{square root over (V/(Lπ))} where V is the syringe volume, and L isthe fixed length of the indicia. For example, using this formula a 10 ccsyringe 48′ with a fixed length of 5 cm may have an inner radius of0.798 cm, while a 20 cc syringe with the same fixed length may have aninner radius of 1.128 cm.

FIG. 43 is a side view of a syringe such as those shown in FIG. 42,illustrated with the plunger shown in the fully depressed and fullyretracted (broken line) positions, according to embodiments of theinvention. The fully depressed position illustrates where the plunger41′ has been pushed forward and the fluid evacuated from the syringebody 48′. The fully retracted position illustrates where the plunger 41′has been pulled back to the greatest volume shown on the syringeindicia. The plunger 41′ that fits within a syringe 48′ that meets thisformula may have the same travel distance (L_(I)) 831 as the length ofthe indicia on the syringe 48′. The width (W_(P)) 833 and thickness(T_(P)) 834 of the plunger 41′ may also be fixed, and the radius (R) ofthe plunger 41′ may match the radius of the syringe 48′.

FIG. 44 is a front view of example syringe bodies with different sizesfor use in a common infusion device, according to embodiments of theinvention. An example of a syringe with a smaller diameter R₁ 825configuration is shown as a dotted line, and an example of a syringewith a larger diameter R₂ 826 configuration is shown as a solid line. Insome embodiments, both configurations may have the same size syringeflange 40′ and/or exit 830. In some embodiments, the width (W_(F)) 827,and height (H_(F)) 835 of the flange 40′ may be fixed.

FIG. 45A is a partial schematic side view of an infusion device that canserially and interchangeably hold syringes with different volumes,according to embodiments of the invention. In some embodiments, theinfusion device may detect a volume of a syringe 48 placed within thehousing 62. In some embodiments, the detection may be automatic. One ormore syringe detection sensors 841, such as, for example, an infraredproximity sensor, other proximity sensor, a pressure sensor, an opticalsensor, and/or RFID reader, may detect objects placed in the housing 62.In some embodiments, the proximity sensor 841 may be directed at thesyringe 48. The proximity sensor 841 may be used to measure the distancebetween the housing and the syringe body 48, when placed on thecenterline of the syringe body 48. A larger distance between theproximity sensor 841 and the syringe 48 may indicate the presence of asmaller syringe (e.g. 10 ml), and a smaller distance between theproximity sensor 841 and the syringe 48 may indicate a larger syringe(e.g. 20 ml). Additionally or alternatively, multiple sensors may beused at once to determine syringe size and location.

FIG. 45B is a top view of the infusion device in FIG. 45A containing asyringe 48 of a first size and a syringe detection sensor configuration841/842 according to embodiments of the invention. In this view, twosensors, a midline sensor 841, and a lateral sensor 842, are shown. Insome embodiments, when a syringe 48 with a radius R₁ is held in thehousing 62, the mid-line sensor 841 may indicate that an object ispresent, and the lateral sensor 842 may not indicate that an object ispresent. This may indicate that a smaller syringe 48 was being used (10ml, as one example). This dual sensor configuration may have theadvantage of utilizing a presence detection sensor as compared to adistance detection sensor such as the single midline sensor 841 of FIG.45A.

FIG. 45C is a top view of the infusion device from FIG. 45B containing asyringe 48 of a second size different from the syringe 48 of the firstsize shown in FIG. 45B, according to embodiments of the invention. Inthis view two sensors are shown, a midline sensor 841 and a lateralsensor 842. In some embodiments, when a larger syringe 48 with a radiusR₂ is held in the housing 62, the mid-line sensor 841 may indicate thatan object is present, and the lateral sensor may also indicate that anobject is present. This may indicate that a larger syringe was beingused (20 ml, as one example). In some embodiments, additional sets ofsensors may be used at different axial and/or radial locations to bettercharacterize the syringe location and size.

Variable syringe sizes may impact both pressure and volume transfused.In some embodiments, the sensors 841 and 842 may provide apre-programmed syringe size to a processor 158″ of a volume calculationsystem 818, to calculate the volume infused. Table 2 illustrates volumecalculations for example syringe sizes.

TABLE 2 Volume Infused Based on Syringe Volume Full 50% 25% strokestroke stroke Volume volume volume Syringe Volume (ml) (ml) (ml) 10 ml10 5 2.5 20 ml 20 10 5 30 ml 30 15 7.5In Table 2, three example syringe size are shown indicating the housing62 can serially and interchangeably hold at least these three differentsizes of syringe 48. However, two, four, or other syringe sizes may alsobe possible. The applied pressure may also vary based on plungerdiameter. The previous example demonstrated two syringe plungerdiameters (e.g. R₁ and R₂) which may be possible if used in thisconfiguration. For example, a 10 ml syringe 48 with a fixed length of 5cm may have an inner radius of 0.798 cm, while a 20 ml syringe with thesame fixed length may have an inner radius of 1.128 cm. The user inputforce F, would result in various fluid pressures within the syringe,according the following formula:

${P = \frac{F*C}{\pi \; R^{2}}},$

where P is the fluid pressure in the syringe, F is the user input forceapplied to the handle, C is a constant based on the mechanical advantageof the lever connecting the user input force to the syringe plunger, andR is the radius of the syringe plunger. Example values for this formulaare shown Table 3 below, where C is given as 0.9. The column “LinearPlunger Force” is the horizontal force applied to the plunger resultingfrom a given user input on the lever.

TABLE 3 Pressure Based on Input Force Linear 10 ml 20 ml User InputPlunger Syringe syringe Force Force Pressure Pressure (LBF) (LBF) (PSI)(PSI) 50 45 90 45 70 63 126 63 100 90 180 90 150 135 270 135 167 150 300150

By constraining the body of the syringe 48 at two points, the flange 40′and the exit 830, a variety of syringe sizes may be used within a singlehousing 62 with only one set of receiving slots. For example, in someembodiments 5 cc, 10 cc, 20 cc, 30 cc, 50 cc and/or 60 cc syringes maybe used, though the present invention is not limited thereto. Areceiving slot 50′ in the housing 62 body may restrain the syringeflange 40′, while the circular cutout 35′ may restrain the syringe exit830. The receiving slot 50′ may provide an axial restraint. If theplunger 41′ also remains a constant size, a receiving slot 64′ in theshuttle 56′ may be used to control the plunger 41′ movement on a varietyof syringe sizes. Because the indicia length may be the same between avariety of syringes, the same actuation trigger can work to actuate anyof the syringes used in this system 818. This can allow the use ofmultiple syringe sizes with a single housing 62 design. As illustratedin FIG. 45B compared to FIG. 45C, the smaller diameter syringes R₁, mayhave a larger gap between the walls of the syringe 48 and the housing62, but may still be fully constrained by the exit 830, syringe flange40′, and plunger 41′.

FIG. 45D is a schematic view of a monitoring system 818 for the infusiondevice of FIGS. 45A-45C configured to determine a size of a respectivesyringe, according to embodiments of the invention. The system 818 ofFIG. 45D may include a display 90′ similar to the one illustrated inFIG. 9, a processor 158″, a power source 152, and/or one or more sensors841/842. The display 90′ may include a screen 91′ and buttons 92A/92B.The screen 91′ may allow a use of the infusion device to view thepressure being applied at any given moment. The buttons 92A/92B mayallow the user to interact with the monitoring system to performfunctions such as, for instance, manually entering a syringe size inuse. The display 90′ may be connected to a processor 158″ which mayprovide an indication of pressure. The indication of pressure by theprocessor 158″ may be based in part on input from sensors, such assensors 841 and 842. The processor 158″ may be powered by a power source152. The power source 152 may be a battery or other power source such asa plug-in cord configured to be connected to a power receptacle, but thepresent invention is not limited thereto. The processor 158″ may alsodirect a locking of the infusion device, such as that of the embodimentillustrated in FIGS. 39A and 39B. In some embodiments, the processor 809of FIGS. 39A and 39B may be the same or similar as the processor 158″illustrated in FIG. 45D.

FIG. 46A is a side view of an infusion device incorporating anelectromechanical actuation member 850, according to embodiments of theinvention. FIG. 46B is a side view of the infusion device of FIG. 46Awith the trigger 37 extended, according to embodiments of the invention.As described herein a pin 57 may travel along a cam surface 52C within apath 52P of the lever 52 as the lever 52 rotates. In some embodiments,lever 52 of the infusion device may be mechanically coupled toelectromechanical actuation member 850. The electromechanical actuationmember 850 may comprise a linear actuator or lead screw motor and may beactivated continuously to move a plunger 853 in response to input by theuser. This electromechanical actuation member 850 may serve as analternate actuation member for the system previously disclosed in FIG.11. In some embodiments, the infusion device may include a force sensorwhich detects user input force and the electromechanical actuationmember 850 may assist the user, allowing use of the device withdecreased force. In some embodiments, the actuation member 850 maycontrol substantially all motion and force provided to the syringe. Insome embodiments, the trigger portion 37 of the lever 52 may be embodiedas a button as illustrated in FIG. 11. The electromechanical actuationmember 850 may be anchored to the housing by housing attachment point851, and may be coupled to the lever 52 by lever attachment point 852.Either or both attachment points 851/852 may allow pivoting about theattachment point 851/852.

The electromechanical actuation member 850 may also comprise solenoidwhich may be actuated as determined by a processor 158″. The solenoidmay retract with force, to inhibit the user from being able to impartadditional force to the trigger 37 and plunger 853 until the force isreduced below the not-to-exceed threshold. Locking devices may bereleased by the user pressing a release button, which may electronicallysignal the processer 158″. In some embodiments, the processor 158″ mayrelease a lock device after a pre-determined amount of time has elapsed.

One of ordinary skill in the art will recognized that other devices andconfigurations of motors may be used to actuate the lever 52 withoutdeviating from the present invention.

FIG. 47A is a side view of an embodiment of a handheld infusion deviceincorporating a motor 151′, according to embodiments of the invention.FIG. 47A depicts a rotational motor 151′ which has a bevel gear 860 onthe end of a shaft. FIG. 47A illustrates the syringe 48 with the plunger41 fully advanced. FIG. 47B is a side view of the infusion device ofFIG. 47A in a retracted position, according to embodiments of theinvention. FIG. 47B illustrates the plunger 41 of the syringe 48 fullyretracted by the rotational motor 151′. As described herein a pin 57′may travel along a cam surface 52C within the lever 52′″ to advance theshuttle 56 as the lever 52′″ rotates. A mating bevel gear 861 may beintegrated into the lever 52′″ of the infusion device and centeredaround the pivot point 53″. The motor 151′ may be a stepper or othermotor and/or may use a processor 158′ in order to automatically advanceand retract the shuttle 56 and plunger 41 to the desired point. Abattery 152′ may provide electrical power to the motor 151′. A trigger37′ can be an electronic control button or switch. The control button37′ may allow the user to control the flow of fluid through theoperation of the motor 151′. Additional user inputs may be present toprovide additional control inputs, such as pressure and/or volumetargets and/or limits.

FIG. 48A is a side view of an embodiment of a handheld infusion device859′ incorporating a linear actuator 850′, according to embodiments ofthe invention. FIG. 48A depicts the linear actuator 850′ which isconnected axially to a shuttle 56′. FIG. 48A shows the syringe 48 withthe plunger 41 fully advanced. FIG. 48B is a side view of the infusiondevice 859′ of FIG. 48A in a retracted position, according toembodiments of the invention. FIG. 48B shows the syringe 48 with theplunger 41 fully retracted. The linear actuator 850′ may be controlledby a processor 158′ in order to advance and retract the shuttle 56′ andplunger 41 to the desired point. This embodiment is shown with anin-line handle, and may have indentations 862 for the user's fingers torest during actuation of the control button 37′. A battery 152′ mayprovide electrical power to the system. A trigger 37′ can be anelectronic control button or switch. The control button 37′ may allowthe user to control the flow of fluid through the operation of thelinear actuator 850′. Additional user inputs may be present to provideadditional control inputs, such as pressure and/or volume targets and/orlimits. In some embodiments, the canopy 42′ may not have a protrusion,as illustrated in this configuration.

FIGS. 48A and 48B show generally how the infusion device 859 of FIGS.47A and 47B can be implemented in an infusion device 859′ with an inlineconfiguration. Similarly, while certain embodiments herein areillustrated with a pistol grip configuration, these embodiments may beconfigured to have an in-line handle or “pen-like” body with atrigger/lever.

As also illustrated herein, embodiments of the infusion device may beautomated or manual, and each may be configured in the alternative. Insome embodiments, the trigger may be a manual trigger such as, forexample, trigger 37 illustrated in FIG. 22. In some embodiments, thetrigger may be an automatic trigger, such as, for example, trigger 37′in FIG. 47A.

While the embodiments presented herein are well suited for use with IOinfusion, they may be used in a similar manner to infuse fluids throughan intravenous access point as well. By using universal connectors suchas male/female luer connection, a wide variety of devices may beconnected to the tubing. These devices may also work well with narrowgauge IV needles, which can sometimes cause existing transfusion pumpsto function poorly.

FIG. 49 is an isometric view of a container 900 incorporating aninfusion device 10/10K, pain medication 901 and an interosseous accesssystem 902/903 according to embodiments of the invention. The container900 may contain an interosseous access system, a volume delivery system,and pain management. The interosseous (IO) access system may include asterile IO needle 903 and a delivery system 902. Some examples ofsterile IO needles 901 and delivery systems 902 include the EZ-IO accesssystem from Teleflex of Morrisville, N.C., FAST1 from Pyng Medical ofBritish Columbia, Canada, Jamshidi Intraosseous Needles from Carefusionof Waukegan, Ill., and Bone Injection Gun (B.I.G.) from Persys Medicalof Houston, Tex. The volume delivery system may consist of an infusiondevice 10, and a basic tubing set 10S, which may be included as part ofa sterile tubing kit 10K. The pain management system may containpre-filled syringes 901 of local anesthetic, such as lidocaine. In someembodiments, the pain management system may also include pre-filledsyringes 901 of local anesthetic and prefilled syringes 911 of bufferingagent, such as sodium bicarbonate. The container 900 may have a doorwhich allows easy access for users to obtain any of the three elements,as needed, in an emergency. In some embodiments, the container 900 maybe configured to be placed on a counter. In some embodiments, thecontainer 900 may be configured to be mounted on a wall. In otherembodiments, the container 900 may be configured to be placed in adrawer, mounted to a trolley, hospital cart or other medical device, orunder a bed, though the present invention is not limited thereto.

FIG. 50 illustrates exemplary operations for infusing fluid to a subjectaccording to embodiments of the invention The method of infusing fluidto a subject may include providing a pre-assembled tubing set comprisingat least a first segment of large bore tubing with a length between 3-12feet with one end portion comprising a spike (block 5001), providing aninfusion delivery device (block 5002), attaching the pre-assembledtubing set to the infusion delivery device so that inlet tubing adjacentthe infusion delivery device extends perpendicularly outward from anaxially extending centerline of a syringe held by the infusion deliverydevice so that the inlet tubing adjacent the infusion delivery device isparallel to a flange of the syringe to place volume indicia of thesyringe facing upward (block 5003). Further, the method may includerepetitively, serially actuating a trigger to move a plunger of asyringe held by the infusion delivery device in a first direction tointake fluid into a syringe (block 5004), and then actuating the triggerto move the plunger of the syringe in a second opposing direction todispense fluid from the syringe (block 5005).

In some embodiments, the actuating steps may be carried out to intakeand dispense at least once to prime a fluid flow path extending betweenthe large bore tubing and the syringe, then infusing the fluid from thesyringe to a subject based on the actuating steps from a fluid sourcethrough the syringe into small bore tubing attached to the infusiondelivery device to deliver the infusion fluid to a subject.

In some embodiments, the pre-assembled tubing set (e.g., tubing set 10Sof FIG. 19A) may include the first segment of large bore tubing attachedto a pouch of saline and a second segment of large bore tubing attachedto a pouch of blood or blood product or contrast agent, the first andsecond segments merging into a third segment of large bore tubing thatis attached to an inlet tube extending out a sidewall of a housing ofthe infusion delivery device.

In some embodiments, the method may further include providing a lengthof small bore tubing with a Y connection attached to an exit port of adual check valve held by the infusion delivery device, and injectingfluids or other medications into a port of the small bore tubing priorto infusing the fluid to the subject.

Particular embodiments and features have been described with referenceto the drawings. It is to be understood that these descriptions are notlimited to any single embodiment or any particular set of features, andthat similar embodiments and features may arise or modifications andadditions may be made without departing from the scope of thesedescriptions and the spirit of the appended claims.

1. An apparatus, comprising: a housing having a dispensing end, an upperside, a lower side, a grip extending from the lower side, and sized andconfigured to hold at least a flange of a body of a syringe and aplunger of the syringe with the syringe oriented with the plunger awayfrom the dispensing end of the housing; a shuttle mounted in the housingfor reciprocal translational motion relative to the housing andconfigured to engage the plunger of the syringe, the shuttle including apin; a lever rotationally coupled to the housing at a pivot andincluding an upper portion extending upwardly from the pivot and a lowerportion extending downwardly from the pivot, the upper portion defininga cam path having an upper end and a lower end, the pin of the shuttledisposed within the cam path, the lower portion having a firstconfiguration and a second configuration, the lower portion defining abounded aperture in the first configuration, the aperture partiallybounded by a separable segment of the lower portion that forms a portionof an outer surface of the lever in the first configuration, theseparable segment configured to break during a transition of the lowerportion from the first configuration to the second configuration suchthat the separable segment does not bound the aperture in the secondconfiguration; and a trigger coupled to the lower portion of the leverand extending downwardly relative to the pivot and the lower side of thehousing, the trigger movable between a first position and a secondposition disposed closer to the grip than the first position, the lowerportion of the lever configured to transition from the firstconfiguration to the second configuration in response to an applicationof force on the trigger toward the grip that exceeds a predeterminedforce threshold such that the lever is prevented from applying a forceto the shuttle that causes the pressure of the fluid dispensed from thesyringe to exceed a predetermined maximum pressure.
 2. The apparatus ofclaim 1, wherein the lower portion includes a first segment and a secondsegment, the trigger coupled to the second segment, and the firstsegment, the second segment, and the separable segment collectivelydefine the aperture in the first configuration, the first segment havinga first orientation relative to the second segment in the firstconfiguration and a second orientation relative to the second segment inthe second configuration.
 3. The apparatus of claim 2, wherein theseparable segment is configured to separate into a first separatedportion and a second separated portion during a transition of the lowerportion from the first configuration to the second configuration suchthat the separable segment does not bound the aperture in the secondconfiguration.
 4. The apparatus of claim 3, wherein, when the lowerportion is in the second configuration, the first separated portion iscoupled to the first segment and the second separated portion is coupledto the second segment.
 5. The apparatus of claim 2, wherein, when thelower portion is in the first configuration, the first segment, thesecond segment, and the separable segment are monolithically formed. 6.The apparatus of claim 2, wherein the trigger includes a connector, theconnector disposed in the aperture when the lower portion is in thefirst configuration.
 7. The apparatus of claim 1, wherein the separablesegment has a thickness when the lower portion is in the firstconfiguration, the thickness corresponding to the predetermined forcethreshold.
 8. The apparatus of claim 7, wherein the thickness is betweenabout 0.01 and about 0.1 inches.
 9. The apparatus of claim 1, whereinthe predetermined force threshold is about 100 lbf.
 10. The apparatus ofclaim 1, wherein the predetermined force threshold is between about 70lbf and about 100 lbf.
 11. The apparatus of claim 1, wherein thepredetermined force threshold is about 50 lbf.
 12. The apparatus ofclaim 1, wherein the predetermined maximum pressure is between about 100PSI and about 200 PSI.
 13. The apparatus of claim 1, wherein thepredetermined maximum pressure is between about 200 PSI and about 300PSI.
 14. The apparatus of claim 1, wherein the predetermined maximumpressure is between about 5.8 PSI and about 100 PSI.
 15. An apparatus,comprising: a housing having a dispensing end and sized and configuredto hold at least a flange of a body of a syringe and a plunger of thesyringe with the syringe oriented with the plunger away from thedispensing end of the housing; a shuttle mounted in the housing forreciprocal translational motion relative to the housing and configuredto engage the plunger of the syringe, the shuttle including a pin; andan actuation lever rotationally coupled to the housing at a pivot point,the lever including a first segment extending below the pivot point anda second segment extending above the pivot point, the first segment ofthe actuation lever including a trigger for manual actuation by a userfrom an extended position to a retracted position, the first segmenthaving a first configuration and a second configuration, the firstsegment defining a bounded aperture in the first configuration, theaperture partially bounded by a separable segment of the first segmentthat forms a portion of an outer surface of the lever in the firstconfiguration, the separable segment configured to break during atransition of the first segment from the first configuration to thesecond configuration such that the separable segment does not bound theaperture in the second configuration, the second segment of theactuation lever including an upwardly extending cam defining anon-linear cam path having an upper end, the pin of the shuttle disposedwithin the cam path, the first segment configured to transition from thefirst configuration to the second configuration in response to anapplication of force on the trigger toward the grip that exceeds apredetermined force threshold such that the lever is prevented fromapplying a force to the shuttle that causes the pressure of the fluiddispensed from the syringe to exceed a predetermined maximum pressure.16. The apparatus of claim 15, wherein the first segment includes afirst portion and a second portion, the trigger coupled to the secondportion, and the first portion, the second portion, and the separablesegment collectively define the aperture in the first configuration, thefirst portion having a first orientation relative to the second portionin the first configuration and a second orientation relative to thesecond portion in the second configuration.
 17. The apparatus of claim16, wherein the separable segment is configured to separate into a firstseparated portion and a second separated portion during a transition ofthe lower portion from the first configuration to the secondconfiguration such that the separable segment does not bound theaperture in the second configuration.
 18. The apparatus of claim 17,wherein, when the first segment is in the second configuration, thefirst separated portion is coupled to the first portion and the secondseparated portion is coupled to the second portion.
 19. The apparatus ofclaim 16, wherein, when the first segment is in the first configuration,the first portion, the second portion, and the separable segment aremonolithically formed.
 20. The apparatus of claim 15, wherein thetrigger includes a connector, the connector disposed in the aperturewhen the first segment is in the first configuration.
 21. The apparatusof claim 15, wherein the separable segment has a thickness when thefirst segment is in the first configuration, the thickness correspondingto the predetermined force threshold.
 22. The apparatus of claim 21,wherein the thickness is between about 0.01 and about 0.1 inches. 23.The apparatus of claim 15, wherein the predetermined force threshold isabout 100 lbf.
 24. The apparatus of claim 15, wherein the predeterminedforce threshold is between about 70 lbf and about 100 lbf.
 25. Theapparatus of claim 15, wherein the predetermined force threshold isabout 50 lbf.
 26. The apparatus of claim 15, wherein the predeterminedmaximum pressure is between about 100 PSI and about 200 PSI.
 27. Theapparatus of claim 15, wherein the predetermined maximum pressure isbetween about 200 PSI and about 300 PSI.
 28. The apparatus of claim 15,wherein the predetermined maximum pressure is between about 5.8 PSI andabout 100 PSI.